Phase 3
N=74
Smoking Cessation & Opioid Dependence Treatment Integration
Smoking Cessation · Opioid Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02854800 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Recruitment, Assignment to Treatment, and Retention Rates — 40; 33; 15; 32 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- varenicline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- West Virginia University
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment, Assignment to Treatment, and Retention Rates |
40; 33; 15; 32; 28; 14 | — |
| PRIMARY Percentage of Days on Which Participants Experienced Each Reason for Attrition |
60.3; 43.4; 47.2; 39.8; 37.9; 46.6 | <0.05 sig |
| PRIMARY Number of Study Days With Protocol Non-Adherence |
1105; 40; 305 | — |
| PRIMARY Medication Acceptability for Completers |
2.55; 1.46; 3.09; 2.21; 1.61; 1.92 | <0.05 sig |
| SECONDARY Number of Participants With Cigarette Smoking Quit Attempts and Actual Quit |
2; 2; 2; 0; 1; 2 | — |
| SECONDARY Number of Study Days Until First Cigarette Quit Attempt |
35.5; 11.5; 12.5 | — |
| SECONDARY Cigarettes Smoked Per Day |
18.21; 15.53; 16.00; 14.28; 12.02; 11.18 | <0.05 sig |
| SECONDARY Drug Withdrawal Ratings |
5.03; 4.55; 4.16; 4.37; 3.09; 2.67 | <0.05 sig |
| SECONDARY Expired Air Carbon Monoxide |
46.00; 34.27; 34.25; 34.18; 30.00; 26.13 | <0.05 sig |
| SECONDARY Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc) |
5; 2; 0; 4; 1; 1 | — |
| SECONDARY Readiness to Quit Smoking |
6.17; 5.87; 5.63; 7.50; 7.20; 7.88 | <0.05 sig |
| SECONDARY Number of Participants That Moved in Stage of Change for Quitting Smoking |
4; 1; 0; 7; 6; 4 | — |
Summary
The primary purpose of this study was to examine the feasibility of integrating a smoking cessation intervention for cigarette smokers enrolled in an outpatient program for opioid dependence. The secondary purpose was to compare treatment effects as a function of phase in the outpatient program: 0-90 days (weekly attendance), 90 days-1 year (biweekly attendance), and more than 1 year (monthly attendance).
Eligibility Criteria
Inclusion Criteria
- enrolled in the Comprehensive Opioid Addiction Treatment (COAT) program
- report smoking >10 cigarettes per day for >1 year
- provide an expired air carbon monoxide (CO) reading of >10 parts/million (ppm)
- report interest in making a quit attempt in the next 1-6 months (Contemplation or Preparation stages via the Stage of Change; Prochaska & Diclemente, 1983)
- willing to try varenicline for smoking cessation
Exclusion Criteria
- current engagement in any form of tobacco cessation (e.g., pharmacotherapy)
- current use of contraindicated medications (e.g., theophylline, warfarin, insulin)
- Stage of Change category as Precontemplation (no plans to quit), Action (actively trying to quit), or Maintenance (have already quit)
- self-reported seizures in the past year
- untreated cardiovascular disease
- self-report breast-feeding
- pregnancy (verified by urinalysis)
- not within 4 weeks of advancing to the next COAT group
Data sourced from ClinicalTrials.gov (NCT02854800). 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.