Varenicline and Motivational Advice for Smokers With Substance Use Disorders

NCT00756275 | Completed Results DMC

• 2 other identifiers: 1R01DA024652R01DA024652
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Nicotine Dependence

Keywords

Tobacco Smoking; Smoking Cessation; Nicotine Dependence; Tobacco Use Disorder

Outcome Measures

Primary Outcomes (2)

• 7-day Point-prevalence Smoking Abstinence

  7 -day smoking cessation confirmed by expired alveolar CO levels of \< 10 ppm or salivary cotinine \< 16 ng/ml.

  3 month follow up

• 7-day Point-prevalence Smoking Abstinence

  7 -day smoking cessation confirmed by expired alveolar CO levels of \< 10 ppm or salivary cotinine \< 16 ng/ml.

  6 month follow up

Secondary Outcomes (8)

• Length of Longest Continuous Abstinence

  Weeks 9 to 12

• Percent Smoking Days

  3 month follow up

• Percent Smoking Days

  6 month follow up

• Percent Relapsed to Drug Use

  3 month follow up

• Percent Relapsed to Drug Use

  6 month follow up

Study Arms (2)

Nicotine Replacement + PLA pill

ACTIVE COMPARATOR

Nicotine replacement treatment patch plus matched placebo pill

Drug: Nicotine Replacement Treatment (NRT); Behavioral: Behavioral counseling for smoking cessation

Varenicline + PLA patch

ACTIVE COMPARATOR

Varenicline plus matched placebo patches containing no nicotine

Drug: varenicline; Behavioral: Behavioral counseling for smoking cessation

Interventions

Nicotine Replacement Treatment (NRT) DRUG

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.

Also known as: Nicotine replacement therapy, Nicotine replacement treatment, NRT

Nicotine Replacement + PLA pill

varenicline DRUG

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.

Also known as: VAR, Chantix

Varenicline + PLA patch

Behavioral counseling for smoking cessation BEHAVIORAL

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.

Also known as: Behavioral treatment for smoking cessation, Behavioral counseling for quitting, Behavioral treatment for quitting

Nicotine Replacement + PLA pill; Varenicline + PLA patch

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brown University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Brown University, Center for Alcohol and Addiction Studies

Providence, Rhode Island, 02903, United States

Location

Related Publications (4)

• 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.

  PMID: 18028247 BACKGROUND

• 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.

  PMID: 12500132 BACKGROUND

• 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.

  PMID: 28498504 RESULT

• 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.

  PMID: 28500373 RESULT

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder; Tobacco Smoking

Interventions

Nicotine Replacement Therapy; Varenicline; Behavior Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking; Tobacco Use

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Damaris Rohsenow, PhD
• Organization: Brown University

Damaris_Rohsenow@brown.edu

401-863-6665

Study Officials

• Damaris J Rohsenow, Ph.D.

  Brown University

  PRINCIPAL INVESTIGATOR

• Rosemarie Martin, Ph.D.

  Brown University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Research): Behavioral and Social Sciences

Study Record Dates

• First Submitted: September 19, 2008
• First Posted: September 22, 2008
• Study Start: January 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: September 1, 2014
• Last Updated: August 27, 2018
• Results First Posted: May 8, 2018

Record last verified: 2018-07

Locations

US (1)