Comparing Smoking Treatment Programs for Lighter Smokers - 1

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT00086411
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 260
• Location: 1
• Arms: 4
• Duration (Months): 69
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

The purpose of this study was to compare two different types of Food and Drug Administration (FDA) approved smoking cessation medications (nicotine patch or bupropion) used in conjunction with two levels of counseling. It was hypothesized that the higher level of counseling would have the highest rates of treatment completion and highest rates of abstinence.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use Disorder	Drug: nicotine transdermal system; Drug: bupropion; Behavioral: Medication Management; Behavioral: Mayo Counseling; Drug: placebo patch; Drug: placebo bupropion	Phase 2

Detailed Description

The study compared a minimal level counseling model to a higher level counseling model plus one of two types of FDA approved smoking cessation products (bupropion or the nicotine patch)used to achieve long term abstinence among lighter smokers. Each participant received both products under blinded conditions meaning that neither the participant nor the counselor knew which product was real or a placebo. The primary goal was to determine the combination or combinations of high or low intensity counseling and pharmacotherapy (either bupropion or the nicotine patch) that were most effective for lighter smokers. The main hypothesis was that higher level counseling would contribute to improved outcomes meaning that more counseling would be associated higher abstinence rates following the completion of treatment and at longer term follow-up.

Study Design

• Study Type: Interventional
• Actual Enrollment: 260 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparing Smoking Treatment Programs for Lighter Smokers
• Study Start Date: Sep 1, 2003
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1: Bup+MM bupropion and MM counseling with placebo patch	Drug: bupropion; 150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks; Other Names: Zyban ; Behavioral: Medication Management; Brief manual based therapy; four 15 minute session over 10 weeks.; Drug: placebo patch; placebo patch containing no nicotine
Experimental: 2 Bup+Mayo bupropion and Mayo counseling with placebo patch.	Drug: bupropion; 150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks; Other Names: Zyban ; Behavioral: Mayo Counseling; Manual based therapy; Weekly 30 minute sessions for 10 weeks; Drug: placebo patch; placebo patch containing no nicotine
Placebo Comparator: 3 Patch+MM patch and MM counseling with placebo pills	Drug: nicotine transdermal system; starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks.; Other Names: Nicoderm ; Behavioral: Medication Management; Brief manual based therapy; four 15 minute session over 10 weeks.; Drug: placebo bupropion; placebo pills
Experimental: 4 Patch+Mayo patch and Mayo counseling with placebo pills	Drug: nicotine transdermal system; starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks.; Other Names: Nicoderm ; Behavioral: Mayo Counseling; Manual based therapy; Weekly 30 minute sessions for 10 weeks; Drug: placebo bupropion; placebo pills

Outcome Measures

Primary Outcome Measures

1. Percent Treatment Sessions Attended [52 weeks]

   Completion of Treatment and Smoking Cessation by Two Different Types of Medications and Counseling Types at 12, 26, and 52 Weeks Post-treatment Initiation. The counseling types were Medication Management (MM) and Mayo counseling models. MM counseling was a 4 session lower intensity counseling model and Mayo counseling was a 10 session higher intensity model. A twofold definition of treatment completion included both medication and counseling session adherence. Treatment completion was defined as consistently taking the active medication as prescribed (80%) of the time during the medication period and attending at least 7 of the 10 required High C sessions or 3 of the 4 Low C sessions. Participants had to meet both requirements to be designated as full treatment completers. Seven-day point prevalence abstinence was the primary measure of abstinence at follow-up Weeks 12, 24, and 52. Abstinence was confirmed by biochemical testing.

Secondary Outcome Measures

1. Delineate Mediators Associated With Different Treatment Conditions (i.e., Medication Compliance, Participant Views of Self-help Written Materials and Counseling Type. [52 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Light smokers (6-15 cigarettes per day

Inclusion Criteria:

Mentally and physically stable, non-pregnant, light smokers (6-15 cigarettes per day)

Exclusion Criteria:

Please contact site for more information

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104 6178

Sponsors and Collaborators

• University of Pennsylvania
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Peter W Gariti, Ph.D., University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

• Gariti P, Levin S, Whittingham T, Barou D, Kampman KM, Lynch K, Halbert CH, Alterman A. Why do those who request smoking treatment fail to attend the first appointment? J Subst Abuse Treat. 2008 Jul;35(1):62-7. Epub 2007 Oct 10.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT00086411
• Other Study ID Numbers: NIDA-15365-1; R01DA015365
• First Posted: Jul 7, 2004
• Last Update Posted: Aug 6, 2019
• Last Verified: Jul 1, 2019

• Keywords provided by University of Pennsylvania: light smokers, smoking cessation treatment programs
• Additional relevant MeSH terms: Tobacco Use Disorder; Bupropion; Nicotine

Study Results

Participant Flow

Recruitment Details	The sample consists of 260 self-referred lighter smokers to an urban university setting. The first participant was enrolled in February 2005, and the last follow-up was completed in March 2008. A total of 302 met confirmatory screening criteria, and 260 were enrolled.
Pre-assignment Detail	An in-person confirmatory screening interview consisted of a medical examination, structured psychological interview (Mini International Neuropsychiatric Interview; Sheenan et al., 1997), and biochemical testing (i.e., carbon monoxide reading of expired air [CO], blood alcohol concentration,and urine drug test).

Arm/Group Title	1 Bup+MM	2 Bup+Mayo	3 Patch+MM	4 Patch+Mayo
Arm/Group Description	bupropion and MM with placebo patch	bupropion and Mayo counseling with placebo patch.	patch and MM with placebo pills	patch and Mayo counseling with placebo patch
Period Title: Overall Study
STARTED	70	63	62	65
COMPLETED	59	52	49	53
NOT COMPLETED	11	11	13	12

Baseline Characteristics

Arm/Group Title	1: Bup+MM	2 Bup+Mayo	3 Patch+MM	4 Patch+Mayo	Total
Arm/Group Description	bupropion and MM with placebo patch	bupropion and Mayo counseling with placebo patch.	patch and MM with placebo pills	patch and Mayo counseling with placebo patch	Total of all reporting groups
Overall Participants	70	63	62	65	260
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.3 (12.5)	42.4 (12.6)	45.8 (12.6)	43.1 (11.3)	43.3 (12.2)
Sex: Female, Male (Count of Participants)
Female	44 62.9%	31 49.2%	35 56.5%	38 58.5%	148 56.9%
Male	26 37.1%	32 50.8%	27 43.5%	27 41.5%	112 43.1%
Region of Enrollment (participants) [Number]
United States	70 100%	63 100%	62 100%	65 100%	260 100%

Outcome Measures

1. Primary Outcome

Title	Percent Treatment Sessions Attended
Description	Completion of Treatment and Smoking Cessation by Two Different Types of Medications and Counseling Types at 12, 26, and 52 Weeks Post-treatment Initiation. The counseling types were Medication Management (MM) and Mayo counseling models. MM counseling was a 4 session lower intensity counseling model and Mayo counseling was a 10 session higher intensity model. A twofold definition of treatment completion included both medication and counseling session adherence. Treatment completion was defined as consistently taking the active medication as prescribed (80%) of the time during the medication period and attending at least 7 of the 10 required High C sessions or 3 of the 4 Low C sessions. Participants had to meet both requirements to be designated as full treatment completers. Seven-day point prevalence abstinence was the primary measure of abstinence at follow-up Weeks 12, 24, and 52. Abstinence was confirmed by biochemical testing.
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1: Bup+MM	2 Bup+Mayo	3 Patch+mm	4 Patch+Mayo
Arm/Group Description	bupropion and MM with placebo patch	bupropion and Mayo counseling with placebo patch.	patch and MM with placebo pills	patch and Mayo counseling with placebo patch
Measure Participants	70	63	62	65
Mean (Standard Error) [Percentage of attended tx. sessions]	77.9 (.05)	85.9 (.04)	66.8 (.06)	66.6 (.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1: Bup+MM, 2 Bup+Mayo, 3 Patch+mm, 4 Patch+Mayo
	Comments	Rates of abstinence were addressed using a generalized estimating equations (GEE) logistic regression model. Counseling type and medication type were entered as the main explanatory variables along with time and the interaction of these factors, together with some covariates (described below). The sample size provided 80% power to detect a difference of about 14% between groups across three time points (i.e., 12, 26, and 52 weeks post-treatment initiation.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.017
	Comments	The p-value was adjusted for multiple comparisons.
	Method	GEE model for repeated binary outcomes
	Comments	Model included hx of heavy smoking, elevated depression, cigarettes per day, gender, and race
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.32
	Confidence Interval	(2-Sided) 95%; 0.77 to 2.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.2734
	Estimation Comments	The above was for the main effect of BUP versus NTX on cessation.

2. Secondary Outcome

Title	Delineate Mediators Associated With Different Treatment Conditions (i.e., Medication Compliance, Participant Views of Self-help Written Materials and Counseling Type.
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

PI is no longer with institution. All efforts have been exhausted to locate this data, but no data is available to be reported

Arm/Group Title	1: Bup+MM	2 Bup+Mayo	3 Patch+MM	4 Patch+Mayo
Arm/Group Description	bupropion and MM with placebo patch	bupropion and Mayo counseling with placebo patch.	patch and MM with placebo pills	patch and Mayo counseling with placebo patch
Measure Participants	0	0	0	0

Adverse Events

Time Frame	The reported time frame for study related serious adverse events was 1 year. Two participants died prior to the week 52 follow-up of non-study related problems. The reported time frame for adverse events is the first 12 weeks (3 weeks post medication).
Arm/Group Title	1: Bup+MM		2 Bup+Mayo		3 Patch+mm		4 Patch+Mayo
Arm/Group Description	bupropion and MM with placebo patch		bupropion and Mayo counseling with placebo patch.		patch and MM with placebo pills		patch and Mayo counseling with placebo patch
All Cause Mortality
	1: Bup+MM		2 Bup+Mayo		3 Patch+mm		4 Patch+Mayo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	1: Bup+MM		2 Bup+Mayo		3 Patch+mm		4 Patch+Mayo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/70 (1.4%)		0/63 (0%)		1/62 (1.6%)		0/65 (0%)
General disorders
Death	0/70 (0%)		0/63 (0%)		1/62 (1.6%)		0/65 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death	1/70 (1.4%)		0/63 (0%)		0/62 (0%)		0/65 (0%)
Other (Not Including Serious) Adverse Events
	1: Bup+MM		2 Bup+Mayo		3 Patch+mm		4 Patch+Mayo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/70 (1.4%)		3/63 (4.8%)		0/62 (0%)		2/65 (3.1%)
General disorders
Medication stopped due to reported side effects.	1/70 (1.4%)	1	3/63 (4.8%)	3	0/62 (0%)	0	2/65 (3.1%)	2

Limitations/Caveats

Missing data from some early terminations from treatment (i.e., 2 or less visits) may reflect dissatisfaction with counseling assignment or medication effects.

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.