N/A
N=137
Varenicline and Motivational Advice for Smokers With Substance Use Disorders
Smoking Cessation · Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00756275 ↗Enrolled (actual)
137
Serious AEs
9.5%
Results posted
May 2018
Primary outcome: Primary: 7-day Point-prevalence Smoking Abstinence — 2; 10 participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nicotine Replacement Treatment (NRT) (Drug); varenicline (Drug); Behavioral counseling for smoking cessation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brown University
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 7-day Point-prevalence Smoking Abstinence |
2; 7 | .30 |
| PRIMARY 7-day Point-prevalence Smoking Abstinence |
2; 7 | .30 |
| SECONDARY Length of Longest Continuous Abstinence |
6.25; 7.84 | .50 |
| SECONDARY Percent Smoking Days |
84.52; 77.12 | .36 |
| SECONDARY Percent Smoking Days |
84.52; 77.12 | .36 |
| SECONDARY Percent Relapsed to Drug Use |
8; 18 | .31 |
| SECONDARY Percent Relapsed to Drug Use |
8; 18 | .31 |
| SECONDARY Percent Relapsed to Any Heavy Drinking |
9; 8 | .18 |
| SECONDARY Percent Relapsed to Any Heavy Drinking |
9; 8 | .18 |
| SECONDARY Beck Depression Inventory |
5.19; 5.75 | .75 |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00756275). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.