Project Impact 2: A Culturally Tailored Smoking Cessation Intervention for Latino Smokers

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02596711
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 26
• Location: 1
• Arms: 3
• Actual Duration (Months): 21.7
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The goal of this research study is to learn how 3 different kinds of counseling treatments may help individuals to quit smoking.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use Cessation; Cancer Prevention	Drug: Nicotine Patch; Behavioral: Questionnaires; Other: Carbon Monoxide (CO) Test; Behavioral: Health Education and Handouts; Behavioral: Culturally Tailored Reading Materials; Behavioral: Counseling Sessions	Phase 1/Phase 2

Detailed Description

Baseline Visit:

If you agree to take part in this study, the following tests and procedures will be performed at the beginning of the study:

• You will complete 10 questionnaires about your demographics (age, race, sex, and so on), medical history, smoking status, alcohol use, religion, how "in control" you feel of your own life, and cultural background. These should take about 1½ hours to complete.

• You will complete a carbon monoxide (CO) test to measure the level of carbon monoxide in your body. This test involves blowing your breath through a hand-held device.

• You will learn how to keep a diary about your progress in your attempts to quit smoking. °You must bring this diary with you to every visit.

• You will be asked if you have smoked any non-tobacco substances in the last 2 days. If you have, you will provide an additional CO sample 2 days after the last time you smoked the substance.

• If you can become pregnant, you will have a urine pregnancy test. To take part in this study, you must not be pregnant.3

• The total length of the baseline visit will be approximately 2.5 hours.

Study Groups:

You will be randomly assigned (as in the roll of dice) into 1 of 3 study groups. You will have an equal chance of being in each group. This is done because no one knows if one study group is better, the same, or worse than the other group.

Counseling Sessions:

The study group that you are in will determine the way that health information is presented to you in one-on-one counseling sessions.

• If you are in Group 1, you will receive general health education. The counselor will discuss a health topic (such as sleep, nutrition, and exercise) and how it relates to you and your smoking. The counselor will also give you handouts about the health topic.

• If you are in Group 2, you and the counselor will discuss how your smoking and your culture may relate to each other. The counselor will also provide you with reading materials that highlight how aspects of your culture relate to health, smoking and quitting.

• If you are in Group 3, you will receive the same cultural counseling and handouts that Group 2 received. Also, you will have additional talks about the use of drugs to help you stop smoking and some common feelings that Latinos may experience with being unsuccessful when trying to quit. The counselor will also offer you a plan for using medication successfully.

All participants will attend 3 counseling sessions during the study. Each of these counseling sessions will be audio recorded. Your first counseling session will be at baseline. The other two counseling sessions will be at your Week 2 and Week 6 visits (described below).

All participants will be given a 12 week supply of nicotine patches and information about how to use the nicotine patch. At each study visit, you will be given the amount of patches that you need to last you to your next visit, plus a few extra in the event that a patch falls off or is damaged.

During your first counseling session, you will be asked to choose a quit date. This is simply a date that you would like to begin using the patch and make an attempt to not smoke.

Week 2 and Week 6 Study Visits:

At each of these study visits, all participants will have the following procedures:

• You will complete a brief interview about your progress and any side effects you may be having. This should take about 10 minutes to complete.

• You will complete 2 questionnaires about your tobacco use and satisfaction with the study. These should take about 10 minutes to complete.

• You will complete a CO test.

• You will be asked if you have smoked any other substances, such as marijuana, in the last 2 days. If you have, you will provide an additional CO sample 2 days after the last time you smoked the substance.

Follow-Up Visits:

About 3 months and 6 months after baseline, you will have a follow-up visit. At each of these visits, the following tests and procedures will be performed:

• You will complete the same set of questionnaires about your tobacco and alcohol use, culture, religion, and sense of control that you did at your baseline visit.

• You will complete a CO test.

• You will be asked if you have smoked any non-tobacco substances in the last 2 days. If you have, you will provide an additional CO sample 2 days after the last time you smoked the substance.

Length of Study:

Your study participation will be over after you complete the 6-month follow-up visit.

This is an investigational study. Up to 36 people will be enrolled in this study. All will take part at MD Anderson.

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Project Impact 2: A Culturally Tailored Smoking Cessation Intervention for Latino Smokers
• Actual Study Start Date: Nov 2, 2015
• Actual Primary Completion Date: Aug 22, 2017
• Actual Study Completion Date: Aug 22, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Health Education (HE) Group Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).	Drug: Nicotine Patch; Participants receive 4 weeks of 21 mg, 4 weeks of 14 mg, and 4 weeks of 7 mg patches.; Other Names: NRT ; Behavioral: Questionnaires; Questionnaires regarding tobacco and alcohol use, culture, religion, and sense of control completed at baseline, at weeks 2 and 6, and at 3 and 6 months after baseline.; Other Names: Surveys ; Other: Carbon Monoxide (CO) Test; Carbon monoxide (CO) test given at baseline, at weeks 2 and 6, and at 3 and 6 months after baseline.; Behavioral: Health Education and Handouts; Participants receive general health education and handouts.; Other Names: Pamphlets ; Behavioral: Counseling Sessions; Participants attend 3 counseling sessions during the study.
Experimental: Culturally Tailored Smoking Cessation (CTSC) Group Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).	Drug: Nicotine Patch; Participants receive 4 weeks of 21 mg, 4 weeks of 14 mg, and 4 weeks of 7 mg patches.; Other Names: NRT ; Behavioral: Questionnaires; Questionnaires regarding tobacco and alcohol use, culture, religion, and sense of control completed at baseline, at weeks 2 and 6, and at 3 and 6 months after baseline.; Other Names: Surveys ; Other: Carbon Monoxide (CO) Test; Carbon monoxide (CO) test given at baseline, at weeks 2 and 6, and at 3 and 6 months after baseline.; Behavioral: Culturally Tailored Reading Materials; Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting.; Other Names: Pamphlets ; Behavioral: Counseling Sessions; Participants attend 3 counseling sessions during the study.
Experimental: Culturally Tailored Smoking + Adherence Enhancement (AE) Group Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).	Drug: Nicotine Patch; Participants receive 4 weeks of 21 mg, 4 weeks of 14 mg, and 4 weeks of 7 mg patches.; Other Names: NRT ; Behavioral: Questionnaires; Questionnaires regarding tobacco and alcohol use, culture, religion, and sense of control completed at baseline, at weeks 2 and 6, and at 3 and 6 months after baseline.; Other Names: Surveys ; Other: Carbon Monoxide (CO) Test; Carbon monoxide (CO) test given at baseline, at weeks 2 and 6, and at 3 and 6 months after baseline.; Behavioral: Culturally Tailored Reading Materials; Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting.; Other Names: Pamphlets ; Behavioral: Counseling Sessions; Participants attend 3 counseling sessions during the study.

Outcome Measures

Primary Outcome Measures

1. Intervention Feasibility & Acceptability [Averaged across 3 study visits (Week 0 to Week 12)]

   The central aim of this pilot study was to evaluate the feasibility and acceptability of our treatment interventions. As such, we examined between-group differences on session satisfaction. After completing each session, participants anonymously rated their level of satisfaction with the counseling session. This investigator created scale (Session Satisfaction Scale) used a 5-point Likert scale (from 1 = "Extremely Unsatisfied" to 5 = "Extremely Satisfied"). Mean satisfaction scores were computed for each participant as the average of all session satisfaction scores. Higher scores indicating greater levels of satisfaction. Treatment group session satisfaction group means were tabulated by group (calculated as the average for all participants in each treatment group) and used as a proxy measure of overall intervention acceptability and feasibility.

2. Patch Adherence: Percentage of Days With Patch [This outcome was collected at each study timepoint and measured the 12 weeks of NRT patch treatment.]

   Adherence to NRT patch (days of NRT patch use) collected with the Timeline followback interview procedure.

3. Number of Abstinent Participants [Collected at the 3- and 6-month follow-up visits]

   Rates of biochemically verified 7-day point prevalence smoking abstinence. Collected with the Timeline Follow-back interview procedure and verified with a expired carbon monoxide testing with a Bedfont Smokelyzer monitor.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Adults at least 18 years of age

2. Current smoker (>5 cigarettes per day for the past 3 months)

3. Able to speak and read English or Spanish

4. Agree to participate in the study and be available for 6 weeks of treatment and 6 months of follow-up

5. Willing to set a quit date within 2 weeks of enrollment date

6. Identify as being of Latino heritage, ethnicity, or ancestry

Exclusion Criteria:

1. Individuals suffering from any unstable medical condition precluding the use of NRT (Identified using the Medical History Questionnaire given at baseline)

2. Currently using smokeless tobacco, electronic nicotine delivery systems (ENDS), nicotine replacement therapy, or other smoking cessation treatment

3. Pregnant or nursing

4. Suffering from a severe psychiatric disorder (assessed using self-reporting history of psychiatric diagnosis during the phone screening) that would interfere with participation

5. Diagnosis of substance dependence other than nicotine (screened using DSM IV TR criteria) Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition

6. Individuals that do not have access to a working telephone

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Marcel A. de Dios, PHD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 14, 2016

More Information

Additional Information:

• University of Texas MD Anderson Cancer Center Website

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT02596711
• Other Study ID Numbers: 2015-0585; K01CA160670; NCI-2016-00193
• First Posted: Nov 4, 2015
• Last Update Posted: Mar 10, 2020
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by M.D. Anderson Cancer Center: Cancer Prevention; Tobacco Use Cessation; Nicotine Patch; NRT; Questionnaires; Surveys; Carbon Monoxide Test; CO; Health Education; Handouts; Pamphlets; Counseling sessions
• Additional relevant MeSH terms: Nicotine; Carbon Monoxide

Study Results

Participant Flow

Recruitment Details	Participants were recruited from the Houston metropolitan area (Harris County, Texas) through fliers at community centers and local health clinics as well as through advertisements online and in print newspapers between February of 2016 and January of 2017.
Pre-assignment Detail	During baseline visit (prior to randomization), an expired carbon monoxide sample was collected using Bedfont Micro+Smokerlyzer.Additionally, participants able to become pregnant were required to take a routine hCG urine sample pregnancy test to rule out potential pregnancy.An assessment battery was also administered at the baseline visit.

Arm/Group Title	Health Education (HE)	Culturally-Tailored (CT)	Culturally-Tailored With Adherence Enhancement (CT+AE)
Arm/Group Description	Used as the control condition. Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).	Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).	Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
Period Title: Overall Study
STARTED	9	8	8
Visit 2	9	7	6
Visit 3	7	8	6
3 Month Follow-up	8	6	6
6 Month Follow-up	8	6	5
COMPLETED	8	6	5
NOT COMPLETED	1	2	3

Baseline Characteristics

Arm/Group Title	Health Education (HE)	Culturally-Tailored (CT)	Culturally-Tailored With Adherence Enhancement (CT+AE)	Total
Arm/Group Description	Used as the control condition. Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).	Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).	Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).	Total of all reporting groups
Overall Participants	9	8	8	25
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	9 100%	8 100%	8 100%	25 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]	45.4 (11)	46 (10.94)	40.7 (13.92)	44.1 (11.53)
Sex: Female, Male (Count of Participants)
Female	4 44.4%	3 37.5%	3 37.5%	10 40%
Male	5 55.6%	5 62.5%	5 62.5%	15 60%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	9 100%	8 100%	8 100%	25 100%
Not Hispanic or Latino	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	1 12.5%	0 0%	1 4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	8 88.9%	2 25%	3 37.5%	13 52%
More than one race	1 11.1%	2 25%	2 25%	5 20%
Unknown or Not Reported	0 0%	3 37.5%	3 37.5%	6 24%
Region of Enrollment (Count of Participants)
United States	9 100%	8 100%	8 100%	25 100%

Outcome Measures

1. Primary Outcome

Title	Intervention Feasibility & Acceptability
Description	The central aim of this pilot study was to evaluate the feasibility and acceptability of our treatment interventions. As such, we examined between-group differences on session satisfaction. After completing each session, participants anonymously rated their level of satisfaction with the counseling session. This investigator created scale (Session Satisfaction Scale) used a 5-point Likert scale (from 1 = "Extremely Unsatisfied" to 5 = "Extremely Satisfied"). Mean satisfaction scores were computed for each participant as the average of all session satisfaction scores. Higher scores indicating greater levels of satisfaction. Treatment group session satisfaction group means were tabulated by group (calculated as the average for all participants in each treatment group) and used as a proxy measure of overall intervention acceptability and feasibility.
Time Frame	Averaged across 3 study visits (Week 0 to Week 12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Health Education (HE)	Culturally-Tailored (CT)	Culturally-Tailored With Adherence Enhancement (CT+AE)
Arm/Group Description	Used as the control condition. Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).	Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).	Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
Measure Participants	9	8	8
Mean (Standard Deviation) [score on a scale]	4.87 (0.35)	4.71 (0.48)	4.83 (0.4)

2. Primary Outcome

Title	Patch Adherence: Percentage of Days With Patch
Description	Adherence to NRT patch (days of NRT patch use) collected with the Timeline followback interview procedure.
Time Frame	This outcome was collected at each study timepoint and measured the 12 weeks of NRT patch treatment.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Health Education (HE)	Culturally-Tailored (CT)	Culturally-Tailored With Adherence Enhancement (CT+AE)
Arm/Group Description	Used as the control condition. Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).	Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).	Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
Measure Participants	9	8	8
Mean (Standard Deviation) [percentage of NRT patch days]	64.6 (17.7)	68.6 (13.66)	81.3 (3.32)

3. Primary Outcome

Title	Number of Abstinent Participants
Description	Rates of biochemically verified 7-day point prevalence smoking abstinence. Collected with the Timeline Follow-back interview procedure and verified with a expired carbon monoxide testing with a Bedfont Smokelyzer monitor.
Time Frame	Collected at the 3- and 6-month follow-up visits

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Health Education (HE)	Culturally-Tailored (CT)	Culturally-Tailored With Adherence Enhancement (CT+AE)
Arm/Group Description	Used as the control condition. Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).	Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).	Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
Measure Participants	9	8	8
3-month follow-up	4 44.4%	2 25%	4 50%
6-month follow-up	4 44.4%	2 25%	3 37.5%

Adverse Events

Time Frame	End of treatment and 6 month follow-up
Adverse Event Reporting Description	MD Anderson requires that all Protocol PIs and their designees report all Serious Adverse Events and Adverse Events (n=4) to the MD Anderson IRB on an ongoing bases using a systematic approach with standardized forms. SAE's and AE's are reported as they occur and during each continuation reports submission.
Arm/Group Title	Health Education (HE)		Culturally-Tailored (CT)		Culturally-Tailored With Adherence Enhancement (CT+AE)
Arm/Group Description	Used as the control condition. Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).		Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).		Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
All Cause Mortality
	Health Education (HE)		Culturally-Tailored (CT)		Culturally-Tailored With Adherence Enhancement (CT+AE)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/8 (0%)		0/8 (0%)
Serious Adverse Events
	Health Education (HE)		Culturally-Tailored (CT)		Culturally-Tailored With Adherence Enhancement (CT+AE)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/8 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Health Education (HE)		Culturally-Tailored (CT)		Culturally-Tailored With Adherence Enhancement (CT+AE)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/9 (33.3%)		1/8 (12.5%)		0/8 (0%)
Gastrointestinal disorders
Nausea and changes in appetite, likely related to increase in patch dosage	1/9 (11.1%)	1	0/8 (0%)	0	0/8 (0%)	0
General disorders
Rapid heart rate and anxiety, likely related to patch use	1/9 (11.1%)	1	0/8 (0%)	0	0/8 (0%)	0
Sleep disturbance, constipation, skin irritation and lesion at patch site, lower back pain, phlegm i	0/9 (0%)	0	1/8 (12.5%)	1	0/8 (0%)	0
Psychiatric disorders
Sleep disturbances, anxiety, abnormal taste in mouth, trouble concentrating, sad mood.	0/9 (0%)	0	1/8 (12.5%)	1	0/8 (0%)	0
Mild sleep disturbance and irratbility.	1/9 (11.1%)	1	0/8 (0%)	0	0/8 (0%)	0

Limitations/Caveats

Due to the limited scope, the study was not fully powered for conclusive hypothesis testing of group differences on variables of interest. The analytic strategy focused on descriptive statistics and estimation rather than formal hypothesis testing.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.