Clinical trial NCT00756275: Varenicline and Motivational Advice for Smokers With Substance Use Disorders
Official title: Varenicline and Motivational Advice for Smokers With SUD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Nicotine Dependence
Keywords: Tobacco Smoking
Smoking Cessation
Nicotine Dependence
Tobacco Use Disorder
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-09-22
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: 7-day Point-prevalence Smoking Abstinence
timeFrame: 3 month follow up
measure: 7-day Point-prevalence Smoking Abstinence
timeFrame: 6 month follow up
Secondary outcomes:
measure: Length of Longest Continuous Abstinence
timeFrame: Weeks 9 to 12
measure: Percent Smoking Days
timeFrame: 3 month follow up
measure: Percent Smoking Days
timeFrame: 6 month follow up
measure: Percent Relapsed to Drug Use
timeFrame: 3 month follow up
measure: Percent Relapsed to Drug Use
timeFrame: 6 month follow up
measure: Percent Relapsed to Any Heavy Drinking
timeFrame: 3 month follow up
measure: Percent Relapsed to Any Heavy Drinking
timeFrame: 6 month follow up
measure: Beck Depression Inventory
timeFrame: Week 12
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University, Center for Alcohol and Addiction Studies
state: Rhode Island
Study officials:
affiliation: Brown University
name: Damaris J Rohsenow, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Rosemarie Martin, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Stapleton JA, Watson L, Spirling LI, Smith R, Milbrandt A, Ratcliffe M, Sutherland G. Varenicline in the routine treatment of tobacco dependence: a pre-post comparison with nicotine replacement therapy and an evaluation in those with mental illness. Addiction. 2008 Jan;103(1):146-54. doi: 10.1111/j.1360-0443.2007.02083.x. Epub 2007 Nov 19.
citation: Rohsenow DJ, Monti PM, Colby SM, Martin RA. Brief interventions for smoking cessation in alcoholic smokers. Alcohol Clin Exp Res. 2002 Dec;26(12):1950-1. doi: 10.1097/01.ALC.0000041006.59547.9A. No abstract available.
citation: Rohsenow DJ, Tidey JW, Martin RA, Colby SM, Swift RM, Leggio L, Monti PM. Varenicline versus nicotine patch with brief advice for smokers with substance use disorders with or without depression: effects on smoking, substance use and depressive symptoms. Addiction. 2017 Oct;112(10):1808-1820. doi: 10.1111/add.13861. Epub 2017 Jul 4.
citation: Murphy CM, MacKillop J, Martin RA, Tidey JW, Colby SM, Rohsenow DJ. Effects of varenicline versus transdermal nicotine replacement therapy on cigarette demand on quit day in individuals with substance use disorders. Psychopharmacology (Berl). 2017 Aug;234(16):2443-2452. doi: 10.1007/s00213-017-4635-4. Epub 2017 May 13.