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

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ClinicalTrials.gov Identifier: NCT00756275
Recruitment Status : Completed
First Posted : September 22, 2008
Results First Posted : May 8, 2018
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Damaris J. Rohsenow, Ph.D., 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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Nicotine Dependence Drug: Nicotine Replacement Treatment (NRT) Drug: varenicline Behavioral: Behavioral counseling for smoking cessation Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Varenicline and Motivational Advice for Smokers With SUD
Study Start Date : January 2009
Actual Primary Completion Date : March 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nicotine Replacement + PLA pill
Nicotine replacement treatment patch plus matched 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 treatment for smoking cessation
  • Behavioral counseling for quitting
  • Behavioral treatment for quitting

Active Comparator: Varenicline + PLA patch
Varenicline plus matched placebo patches containing no nicotine
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:
  • 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 treatment for smoking cessation
  • Behavioral counseling for quitting
  • Behavioral treatment for quitting




Primary Outcome Measures :
  1. 7-day Point-prevalence Smoking Abstinence [ Time Frame: 3 month follow up ]
    7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.

  2. 7-day Point-prevalence Smoking Abstinence [ Time Frame: 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 :
  1. Length of Longest Continuous Abstinence [ Time Frame: Weeks 9 to 12 ]
  2. Percent Smoking Days [ Time Frame: 3 month follow up ]
  3. Percent Smoking Days [ Time Frame: 6 month follow up ]
  4. Percent Relapsed to Drug Use [ Time Frame: 3 month follow up ]
  5. Percent Relapsed to Drug Use [ Time Frame: 6 month follow up ]
  6. Percent Relapsed to Any Heavy Drinking [ Time Frame: 3 month follow up ]
    6 or more drinks for men; 5 or more drinks for women

  7. Percent Relapsed to Any Heavy Drinking [ Time Frame: 6 month follow up ]
    6 or more drinks for men; 5 or more drinks for women

  8. Beck Depression Inventory [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00756275


Locations
United States, Rhode Island
Brown University, Center for Alcohol and Addiction Studies
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Brown University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Damaris J Rohsenow, Ph.D. Brown University
Study Director: Rosemarie Martin, Ph.D. Brown University

Publications of Results:
Other Publications:
Responsible Party: Damaris J. Rohsenow, Ph.D., Professor (Research): Behavioral and Social Sciences, Brown University
ClinicalTrials.gov Identifier: NCT00756275     History of Changes
Other Study ID Numbers: 1R01DA024652 ( U.S. NIH Grant/Contract )
R01DA024652 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2008    Key Record Dates
Results First Posted: May 8, 2018
Last Update Posted: May 8, 2018
Last Verified: April 2018

Keywords provided by Damaris J. Rohsenow, Ph.D., 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
Nicotine
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action