Varenicline and Motivational Advice for Smokers With Substance Use Disorders

NACompletedINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

March 31, 2014

Study Completion Date

September 30, 2014

Conditions
Smoking CessationNicotine Dependence
Interventions
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.

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.

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.

Trial Locations (1)

02903

Brown University, Center for Alcohol and Addiction Studies, Providence

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Brown University

OTHER

NCT00756275 - Varenicline and Motivational Advice for Smokers With Substance Use Disorders | Biotech Hunter | Biotech Hunter