Varenicline and Motivational Advice for Smokers With Substance Use Disorders

Not Applicable

Completed

• Conditions: Nicotine Dependence; Smoking Cessation
• Interventions: Drug: Nicotine Replacement Treatment (NRT); Drug: varenicline; Behavioral: Behavioral counseling for smoking cessation

• Registration Number: NCT00756275
• Lead Sponsor: Brown University

Brief Summary

The purpose of this study is to evaluate the effects of 12 weeks of varenicline as compared to nicotine replacement therapy for smoking cessation among outpatients in treatment for substance use disorders. The intervention also incorporates counseling (Brief Advice), (adapted for sobriety settings), skills training and medication management.

Detailed Description

People with substance use disorders (SUD) have a high prevalence and rate of smoking with little success in quitting, so stronger approaches are needed to encourage attempts to quit smoking. Brief advice (BA), to motivate cessation, produced some benefit but low abstinence rates for smokers with SUDs while adding free transdermal nicotine replacement therapy (NRT) improved short-term cessation rates. Varenicline has been found to produce higher rates of short and long-term abstinence than bupropion or placebo. However, a comparison between the efficacy of varenicline and NRT has not yet conducted with people with SUDs. Given the lack of effectiveness for standard smoking treatments for this population, what needs to be known is whether varenicline would increase the smoking abstinence rates relative to NRT when all receive motivational counseling.

The primary aim of this study is to evaluate the effects of 12 weeks of varenicline as compared to NRT, using a two-group randomized placebo-controlled design on smoking cessation rates for 12 months among 274 outpatients in treatment for SUD. The counseling incorporates BA (adapted slightly for sobriety settings by directly addressing barriers and concerns expressed by substance abusers), skills training and medication management. Confirmed point-prevalence and sustained abstinence will be assessed at 3 and 6 a months after the start of treatment. Secondary aims will examine potential mediators of effect including within-treatment abstinence, craving, and nicotine withdrawal levels.

The potential significance is to add to knowledge about the most effective ways to maximize smoking cessation among substance abusers, important given that no methods are known to work with this difficult population. No study published to date has compared varenicline to NRT for efficacy with patients with SUD.

Study Timeline

• Study First Submitted: 2008-09-19
• Study First Submitted QC: 2008-09-19
• Study First Posted: 2008-09-22
• Study Start: 2009-01
• Primary Completion: 2014-03
• Study Completion: 2014-09
• Results First Submitted: 2017-08-25
• Results First Submitted QC: 2018-04-06
• Results First Posted: 2018-05-08
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-27
• Last Update Posted: 2018-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

• Diagnosis of substance abuse or dependence by DSM-IV criteria
• Currently smoking at least 10 cigarettes per day for the past 6 months

Exclusion Criteria

• Active psychosis or marked organic impairment according to medical records, or evidence of hallucinations or delusions
• Current use of any nicotine replacement, or other smoking cessation treatment
• Medical contraindications for NRT (including pregnancy, nursing, women not using birth control during heterosexual sex, history of unstable angina, history of severe congestive heart failure, uncontrolled hypertension, lung cancer, supplemental oxygen, allergy to adhesive, severe skin disease that requires treatment)
• Medical contraindications for VAR (including pregnancy, nursing, severe renal impairment by laboratory test, history of intolerance of varenicline, history of serious suicidal ideation or attempts in the past 5 years)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicotine Replacement + PLA pill	Nicotine Replacement Treatment (NRT)	Nicotine replacement treatment patch plus matched placebo pill
Varenicline + PLA patch	Behavioral counseling for smoking cessation	Varenicline plus matched placebo patches containing no nicotine
Nicotine Replacement + PLA pill	Behavioral counseling for smoking cessation	Nicotine replacement treatment patch plus matched placebo pill
Varenicline + PLA patch	varenicline	Varenicline plus matched placebo patches containing no nicotine

Primary Outcome Measures

Name	Time	Method
7-day Point-prevalence Smoking Abstinence	6 month follow up	7 -day smoking cessation confirmed by expired alveolar CO levels of \< 10 ppm or salivary cotinine \< 16 ng/ml.

Secondary Outcome Measures

Name	Time	Method
Length of Longest Continuous Abstinence	Weeks 9 to 12
Percent Relapsed to Drug Use	6 month follow up
Percent Relapsed to Any Heavy Drinking	6 month follow up	6 or more drinks for men; 5 or more drinks for women
Percent Smoking Days	6 month follow up
Beck Depression Inventory	Week 12	0-10 = These ups and downs are considered normal 11-16 = Mild mood disturbance 17-20 = Borderline clinical depression 21-30 = Moderate depression 31-40 = Severe depression over 40 = Extreme depression

Trial Locations

Locations (1)

Brown University, Center for Alcohol and Addiction Studies; 🇺🇸 Providence, Rhode Island, United States