Varenicline and Motivational Advice for Smokers With Substance Use Disorders
Condition: Smoking Cessation; Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

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.
    

Intervention name(s): Nicotine Replacement Treatment (NRT); varenicline; Behavioral counseling for smoking cessation
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Nicotine replacement treatment (NRT) will follow the clinical practice guidelines for nicotine patch for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use (tapering recommended for people with AUDs by Hughes et al., 2003b): 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks.; Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks.; The counseling consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after Quit Day.
Other intervention name(s): Nicotine replacement therapy; Nicotine replacement treatment; NRT; VAR; Chantix; Behavioral treatment for smoking cessation; Behavioral counseling for quitting; Behavioral treatment for quitting
Intervention MeSH terms: Nicotine; Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tobacco Smoking; Smoking Cessation; Nicotine Dependence; Tobacco Use Disorder