Varenicline and Motivational Advice for Smokers With Substance Use Disorders (VARSUD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Brown University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Brown University
ClinicalTrials.gov Identifier:
NCT00756275
First received: September 19, 2008
Last updated: June 24, 2011
Last verified: February 2009
  Purpose

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.


Condition Intervention
Smoking Cessation
Nicotine Dependence
Drug: Nicotine Replacement Treatment (NRT)
Drug: varenicline
Behavioral: Behavioral counseling for smoking cessation
Drug: Placebo patch
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Varenicline and Motivational Advice for Smokers With SUD

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • 7-day point-prevalence abstinence [ Time Frame: Assessed at 3, 6, and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first smoking lapse in days, length of longest continuous abstinence, and percent days abstinent. [ Time Frame: 1, 4, 8,13, 26, 52 weeks post quit ] [ Designated as safety issue: No ]

Estimated Enrollment: 274
Study Start Date: January 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Nicotine replacement treatment plus placebo pill
Drug: Nicotine Replacement Treatment (NRT)
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.
Other Names:
  • Nicotine replacement therapy
  • Nicotine replacement treatment
  • NRT
Behavioral: Behavioral counseling for smoking cessation
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 Names:
  • Behavioral counseling for smoking cessation
  • Behavioral treatment for smoking cessation
  • Behavioral counseling for quitting
  • Behavioral treatment for quitting
Drug: Placebo
The placebos use identical opaque capsules to the varenicline condition, containing inert filler. Participant takes 1 placebo capsule per day for the first 3 days and 2 per day for 4 days and 12 weeks.
Active Comparator: B
Varenicline plus placebo patches
Drug: varenicline
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.
Other Names:
  • varenicline
  • VAR
  • Chantix
Behavioral: Behavioral counseling for smoking cessation
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 Names:
  • Behavioral counseling for smoking cessation
  • Behavioral treatment for smoking cessation
  • Behavioral counseling for quitting
  • Behavioral treatment for quitting
Drug: Placebo patch
Commercially available matched placebo patches will be used for 12 weeks.

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, 6 and 12 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756275

Contacts
Contact: Jennifer J Duff, M.A. (401) 863-6667 Jennifer_Larence@brown.edu

Locations
United States, Rhode Island
Brown University, Center for Alcohol and Addiction Studies Recruiting
Providence, Rhode Island, United States, 02903
Contact: Damaris Rohsenow, Ph.D.         
Principal Investigator: Damaris J Rohsenow, Ph.D.         
Sponsors and Collaborators
Brown University
Investigators
Principal Investigator: Damaris J Rohsenow, Ph.D. Brown University
Study Director: Rosemarie Martin, Ph.D. Brown University
  More Information

Publications:
Responsible Party: Damaris J. Rohsenow, Ph.D. / Principal Investigator, Brown University
ClinicalTrials.gov Identifier: NCT00756275     History of Changes
Other Study ID Numbers: 1RO1DA02465201, NIH Appl. ID: 7439661, NIH Award: RDA024652A
Study First Received: September 19, 2008
Last Updated: June 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Brown University:
Tobacco Smoking
Smoking Cessation
Nicotine Dependence
Tobacco Use Disorder

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Varenicline
Nicotine
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014