Mobile Health Technology to Enhance Abstinence in Smokers With Schizophrenia

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02420015
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 2
• Actual Duration (Months): 21.9
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

This study is designed to evaluate if a treatment the investigators call iCOMMIT is effective at helping smokers with schizophrenia stop smoking. iCOMMIT is a smoking cessation treatment that combines mobile technology with behavioral strategies, counseling, and medications.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Cigarette Smoking	Drug: Nicotine replacement therapy; Drug: Bupropion; Behavioral: cognitive-behavioral smoking cessation counseling; Behavioral: Mobile Contingency Management; Behavioral: Stay Quit Coach; Behavioral: SMS text messaging	Phase 4

Detailed Description

The purpose of this 2-arm randomized controlled trial (RCT) is to evaluate the efficacy of Multi-Component Mobile-enhanced Treatment for Smoking Cessation (iCOMMIT) in helping individuals with schizophrenia or other psychotic disorders stop smoking. Eligible participants will be randomized to receive iCOMMIT, which includes smoking cessation counseling, pharmacotherapy, and mobile technology components, or a control intervention that includes smoking cessation counseling and pharmacotherapy, but no mobile technology components. The control condition represents an intensive standard of care and helps control for monitoring, counselor, time, and attention effects.

The primary outcome for the study will be self-reported and bio-verified prolonged smoking abstinence at the 6-month follow-up. Self-reported prolonged abstinence will be verified by saliva cotinine assay. Secondary outcomes will include 7- and 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 or 30 days.

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Mobile Health Technology to Enhance Abstinence in Smokers With Schizophrenia
• Actual Study Start Date: Mar 27, 2017
• Actual Primary Completion Date: Jan 24, 2019
• Actual Study Completion Date: Jan 24, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: iCOMMIT The components of the intervention include 1) behavioral therapy in the form of mobile contingency management (mCM) designed to increase early abstinent rates; 2) pharmacotherapy for smoking cessation [including nicotine replacement therapy (NRT) and bupropion]; 3) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation; 4) a smart-phone based relapse prevention application (the Stay Quit Coach) that is populated during the counseling sessions; and 5) SMS text messaging reminders to increase medication adherence.	Drug: Nicotine replacement therapy; Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum, nicotine inhaler, or nicotine nasal spray, and will be instructed to use the rescue method as needed to reduce cigarette cravings; Other Names: nicotine gum, patch, inhaler, and/or lozenge ; Drug: Bupropion; All participants who are medically eligible will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 3-month follow-up; Other Names: Zyban ; Behavioral: cognitive-behavioral smoking cessation counseling; Participants will receive four 20-minute smoking cessation counseling sessions and a participant manual. The four sessions are based on standard cognitive-behavioral therapy techniques shown to be efficacious for smoking cessation.; Behavioral: Mobile Contingency Management; Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for videos that suggest smoking abstinence.; Other Names: mCM ; Behavioral: Stay Quit Coach; Stay Quit Coach is a smart phone application that serves as a source of readily available support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment. The app guides user in creating tailored plans that include their personal reasons for quitting, interactive tools to help users cope with urges to smoke, motivational messages, support contacts to help users stay smoke free and how to address lapses. Participants assigned to this condition will be asked to use Stay Quit Coach from Session 2 through the 6-month follow-up.; Behavioral: SMS text messaging; Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt, including messages reminding participants to take their smoking cessation medication.; Other Names: texting
Active Comparator: Control Group The components of the intervention include 1) pharmacotherapy for smoking cessation [including nicotine replacement therapy (NRT) and bupropion]; and 2) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation.	Drug: Nicotine replacement therapy; Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum, nicotine inhaler, or nicotine nasal spray, and will be instructed to use the rescue method as needed to reduce cigarette cravings; Other Names: nicotine gum, patch, inhaler, and/or lozenge ; Drug: Bupropion; All participants who are medically eligible will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 3-month follow-up; Other Names: Zyban ; Behavioral: cognitive-behavioral smoking cessation counseling; Participants will receive four 20-minute smoking cessation counseling sessions and a participant manual. The four sessions are based on standard cognitive-behavioral therapy techniques shown to be efficacious for smoking cessation.

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Self-report Prolonged Abstinence [6 month follow-up]

   Prolonged abstinence will exclude tobacco use in the first two weeks following the quit date, as is consistent with other smoking cessation trials.

2. Number of Participants Whose Prolonged Abstinence is Bio-verified [6 month follow-up]

   Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence at each follow-up.

Secondary Outcome Measures

1. Number of Participants Who Report 7 Day Point Prevalence Abstinence [3 months post-quit attempt (Session 5)]

   Secondary smoking outcomes will include 7-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 days.

2. Number of Participants Who Report 30 Day Point Prevalence Abstinence [3 months post-quit attempt (Session 5)]

   Secondary smoking outcomes will include 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 30 days.

3. Number of Participants Who Report 7 Day Point Prevalence Abstinence [6 months post-quit attempt (Session 6)]

   Secondary smoking outcomes will include 7-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 days.

4. Number of Participants Who Report 30 Day Point Prevalence Abstinence [6 months post-quit attempt (Session 6)]

   Secondary smoking outcomes will include 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 30 days.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Currently smoke at least ten cigarettes a day

• Have been smoking for at least one year

• Meet criteria for schizophrenia, schizoaffective disorder, or another psychotic disorder based on structured clinical interview

• Can speak and write fluent conversational English

• Are between 18 and 70 years of age

• Are willing to make a smoking cessation attempt

• Score 26 or higher on the Montreal Cognitive Assessment

Exclusion Criteria:

• Have a history of myocardial infarction in the past 6 months

• Have a contraindication to NRT with no medical clearance from the primary care provider or study physician

• Use and unwillingness to stop use of other forms of nicotine such as cigars, pipes, or chewing tobacco

• Are pregnant

• Meet criteria for a current manic episode based on structured clinical interview

• Are currently enrolled in another smoking cessation trial

• Are currently imprisoned or in psychiatric hospitalization

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27706

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Jean C Beckham, Ph.D., Duke University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 24, 2018

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02420015
• Other Study ID Numbers: Pro00061683
• First Posted: Apr 17, 2015
• Last Update Posted: Jul 10, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Schizophrenia; Bupropion; Nicotine

Study Results

Participant Flow

Pre-assignment Detail	One participant was deemed ineligible to participate in the study prior to randomization because that participant couldn't read or write English.

Arm/Group Title	iCOMMIT	Control Group
Arm/Group Description	Components include: mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter) 4 sessions cognitive-behavioral smoking cessation counseling; Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt.	Components include: pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter) 4 sessions cognitive-behavioral smoking cessation counseling;
Period Title: Overall Study
STARTED	21	13
COMPLETED	21	13
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	iCOMMIT	Control Group	Total
Arm/Group Description	Components include: mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter) 4 sessions cognitive-behavioral smoking cessation counseling; Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt.	Components include: pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter) 4 sessions cognitive-behavioral smoking cessation counseling;	Total of all reporting groups
Overall Participants	21	13	34
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.24 (10.30)	46.92 (10.30)	48.39 (10.20)
Sex: Female, Male (Count of Participants)
Female	7 33.3%	3 23.1%	10 29.4%
Male	14 66.7%	10 76.9%	24 70.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 4.8%	0 0%	1 2.9%
Not Hispanic or Latino	20 95.2%	13 100%	33 97.1%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 4.8%	0 0%	1 2.9%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	13 61.9%	6 46.2%	19 55.9%
White	3 14.3%	1 7.7%	4 11.8%
More than one race	4 19%	4 30.8%	8 23.5%
Unknown or Not Reported	0 0%	2 15.4%	2 5.9%
Region of Enrollment (participants) [Number]
United States	21 100%	13 100%	34 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Self-report Prolonged Abstinence
Description	Prolonged abstinence will exclude tobacco use in the first two weeks following the quit date, as is consistent with other smoking cessation trials.
Time Frame	6 month follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	iCOMMIT	Control Group
Arm/Group Description	Components include: mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter) 4 sessions cognitive-behavioral smoking cessation counseling; Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt.	Components include: pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter) 4 sessions cognitive-behavioral smoking cessation counseling;
Measure Participants	21	13
Count of Participants [Participants]	6 28.6%	3 23.1%

2. Primary Outcome

Title	Number of Participants Whose Prolonged Abstinence is Bio-verified
Description	Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence at each follow-up.
Time Frame	6 month follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	iCOMMIT	Control Group
Arm/Group Description	Components include: mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter) 4 sessions cognitive-behavioral smoking cessation counseling; Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt.	Components include: pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter) 4 sessions cognitive-behavioral smoking cessation counseling;
Measure Participants	21	13
Count of Participants [Participants]	3 14.3%	2 15.4%

3. Secondary Outcome

Title	Number of Participants Who Report 7 Day Point Prevalence Abstinence
Description	Secondary smoking outcomes will include 7-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 days.
Time Frame	3 months post-quit attempt (Session 5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	iCOMMIT	Control Group
Arm/Group Description	Components include: mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter) 4 sessions cognitive-behavioral smoking cessation counseling; Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt.	Components include: pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter) 4 sessions cognitive-behavioral smoking cessation counseling;
Measure Participants	21	13
Count of Participants [Participants]	2 9.5%	1 7.7%

4. Secondary Outcome

Title	Number of Participants Who Report 30 Day Point Prevalence Abstinence
Description	Secondary smoking outcomes will include 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 30 days.
Time Frame	3 months post-quit attempt (Session 5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	iCOMMIT	Control Group
Arm/Group Description	Components include: mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter) 4 sessions cognitive-behavioral smoking cessation counseling; Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt.	Components include: pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter) 4 sessions cognitive-behavioral smoking cessation counseling;
Measure Participants	21	13
Count of Participants [Participants]	2 9.5%	1 7.7%

5. Secondary Outcome

Title	Number of Participants Who Report 7 Day Point Prevalence Abstinence
Description	Secondary smoking outcomes will include 7-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 days.
Time Frame	6 months post-quit attempt (Session 6)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	iCOMMIT	Control Group
Arm/Group Description	Components include: mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter) 4 sessions cognitive-behavioral smoking cessation counseling; Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt.	Components include: pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter) 4 sessions cognitive-behavioral smoking cessation counseling;
Measure Participants	21	13
Count of Participants [Participants]	4 19%	2 15.4%

6. Secondary Outcome

Title	Number of Participants Who Report 30 Day Point Prevalence Abstinence
Description	Secondary smoking outcomes will include 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 30 days.
Time Frame	6 months post-quit attempt (Session 6)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	iCOMMIT	Control Group
Arm/Group Description	Components include: mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter) 4 sessions cognitive-behavioral smoking cessation counseling; Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt.	Components include: pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter) 4 sessions cognitive-behavioral smoking cessation counseling;
Measure Participants	21	13
Count of Participants [Participants]	1 4.8%	2 15.4%

Adverse Events

Time Frame	Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
Arm/Group Title	iCOMMIT		Control Group
Arm/Group Description	Components include: mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter) 4 sessions cognitive-behavioral smoking cessation counseling; Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt.		Components include: pharmacotherapy for smoking cessation: Includes nicotine replacement therapy [nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter) 4 sessions cognitive-behavioral smoking cessation counseling;
All Cause Mortality
	iCOMMIT		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/13 (0%)
Serious Adverse Events
	iCOMMIT		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/21 (9.5%)		3/13 (23.1%)
Psychiatric disorders
Hospitalization	2/21 (9.5%)	2	3/13 (23.1%)	4
Other (Not Including Serious) Adverse Events
	iCOMMIT		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/21 (61.9%)		12/13 (92.3%)
Eye disorders
Eye infection	0/21 (0%)	0	1/13 (7.7%)	1
Gastrointestinal disorders
Nausea, upset stomach	2/21 (9.5%)	2	5/13 (38.5%)	5
General disorders
Mouth and/or throat irritation	3/21 (14.3%)	3	2/13 (15.4%)	2
Flu	2/21 (9.5%)	2	1/13 (7.7%)	1
Pain	1/21 (4.8%)	1	0/13 (0%)	0
Musculoskeletal and connective tissue disorders
Increased foot pain	1/21 (4.8%)	1	1/13 (7.7%)	1
Swelling in leg	0/21 (0%)	0	1/13 (7.7%)	1
Nervous system disorders
Jitteriness, shakiness	2/21 (9.5%)	2	1/13 (7.7%)	1
dizziness	1/21 (4.8%)	1	1/13 (7.7%)	1
Headache	0/21 (0%)	0	1/13 (7.7%)	1
Increased seizures	1/21 (4.8%)	2	0/13 (0%)	0
Psychiatric disorders
Suicidal ideation	3/21 (14.3%)	4	1/13 (7.7%)	1
Sleep problems and/or nightmares	3/21 (14.3%)	4	1/13 (7.7%)	1
Increased psychiatric symptoms	1/21 (4.8%)	2	1/13 (7.7%)	1
Respiratory, thoracic and mediastinal disorders
Asthma	1/21 (4.8%)	2	0/13 (0%)	0
Benign tumor removed from lung	1/21 (4.8%)	1	0/13 (0%)	0
Skin and subcutaneous tissue disorders
Skin irritation	2/21 (9.5%)	2	0/13 (0%)	0
Sweating	1/21 (4.8%)	1	0/13 (0%)	0
Social circumstances
Altercation with police	0/21 (0%)	0	1/13 (7.7%)	1
Family violence	2/21 (9.5%)	2	0/13 (0%)	0
Rape	0/21 (0%)	0	1/13 (7.7%)	1
Car accident	1/21 (4.8%)	1	0/13 (0%)	0
Death in family	0/21 (0%)	0	1/13 (7.7%)	1
Surgical and medical procedures
Dental surgery	1/21 (4.8%)	2	0/13 (0%)	0

Limitations/Caveats

[Not Specified]

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.