Overview

Varenicline and Motivational Advice for Smokers With Substance Use Disorders

Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Brown University
Collaborator:
National Institute on Drug Abuse (NIDA)
Treatments:
Nicotine
Varenicline
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)