Smoking Cessation & Opioid Dependence Treatment Integration

Phase 2

Completed

Conditions: Smoking Cessation
Opioid Related Disorders

Interventions: Drug: varenicline

Registration Number: NCT02854800

Lead Sponsor: West Virginia University

Brief 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).

Detailed Description: Tobacco smoking rates are substantially higher among individuals with substance use disorders (SUDs), relative to individuals in the general population (e.g., 97% vs. 19%, respectively). Yet most treatment programs for SUDs fail to address the use of tobacco among patients, and integration of smoking cessation treatment with SUD treatment may improve outcomes for both drugs. The question remains, however, whether to implement a smoking cessation component immediately or only after a patient is stabilized on their SUD pharmacotherapy. Existing research that directly addresses this factor is limited and findings are mixed. Therefore, the purpose of this study was to compare drug use outcomes among patients at three different stages of their SUD treatment: 0-90 days (weekly clinic attendance), 90 days-1 year (biweekly clinic attendance), and more than 1 year (monthly clinic attendance) of consistent abstinence from illicit drugs. Smokers currently in treatment for opioid dependence, at the WVU Comprehensive Opioid Addiction Treatment (COAT) program, were recruited to participate in this 12-week study. Our goal was to complete 20 patients from each of the three COAT treatment groups. During the 12-week intervention period, individuals continued to attend their regular COAT clinic appointments while following a standard varenicline (Chantix®) dosing regimen and responding to questions daily via text messaging (e.g., adherence to varenicline, use of tobacco, tobacco withdrawal side effects, etc.). The primary outcomes are those relevant to feasibility: 1) recruitment, randomization, and retention, 2) adherence to medication regimen, and 3) compliance with responding to text message-based questions. Secondary outcomes include a comparison of the three COAT treatment groups on 1) relapses for all substances, 2) the proportion of smokers abstinent at each assessment (confirmed with expired air carbon monoxide samples), 3) days until successful cigarette quit day, 4) substance withdrawal and medication side effect symptoms, 5) motivation to quit tobacco, and 6) cigarette quit attempts.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 74

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biweekly Opioid Tx	varenicline	Participants in this group attended an outpatient opioid clinic once bi-weekly. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
Weekly Opioid Tx	varenicline	Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, they received 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
Monthly Opioid Tx	varenicline	Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack

Primary Outcome Measures

Name	Time	Method
Recruitment, Assignment to Treatment, and Retention Rates	up to 12 weeks	For primary feasibility outcomes, recruitment, assignment to treatment, and retention rates were analyzed using descriptive statistics.
Percentage of Days on Which Participants Experienced Each Reason for Attrition	up to 4 weeks	Drug withdrawal and medication side effect ratings were assessed as potential reasons for attrition. This assessment was completed by calculating the mean percentage of days, out of the first four weeks, during which effects were reported by participants who completed the entire 12-week protocol versus participants that dropped out. We limited this analysis to the first four weeks.
Number of Study Days With Protocol Non-Adherence	up to 12 weeks	Medication non-adherence rates: The number of study days on which participants a) self-reported not taking the medication (i.e. provided a response of "no") or b) had a missing medication response (i.e. provided no response) via text message. Text-messaging non-adherence rates: The number of study days in which participants failed to respond to one or more assessments measured via text message.
Medication Acceptability for Completers	up to 12 weeks	Side effect ratings of nausea, headache, sleep problems, gas/constipation, abnormal dreams, depressed mood, and drowsy; scores ranged from 0-10 and higher scores indicate more severe symptoms.

Secondary Outcome Measures

Name	Time	Method
Cigarettes Smoked Per Day	up to 12 weeks	The number of cigarettes smoked per day were reported via text message by participants daily. These numbers were averaged within weeks to give 12 separate average weekly values for cigarettes per day.
Number of Study Days Until First Cigarette Quit Attempt	up to 12 weeks	A quit attempt was defined as at least one day on which participants reported 0 cigarettes smoked via text message. Reports of \>0 cigarettes on subsequent days was indicative of relapse.
Number of Participants With Cigarette Smoking Quit Attempts and Actual Quit	Up to 12 weeks	A quit attempt was defined as at least one study day on which 0 cigarettes smoked was reported via text message. Actual quit rates were determined by biochemically verified cigarette abstinence, which was an expired air carbon monoxide reading of \< 8 parts per million (ppm).
Drug Withdrawal Ratings	up to 12 weeks	Average self-reported ratings for craving, irritability, restless, alert, bored, calm/relaxed, able to focus, nervous, and other; scores ranged from 0-10 and higher scores indicate higher levels of that withdrawal effect
Expired Air Carbon Monoxide	up to 12 weeks	Expired air carbon monoxide levels were measured for participants every 4 weeks at their in-person study visits, resulting in 4 separate measures across the 12-week period.
Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc)	up to 12 weeks	Relapse was determined by semi-quantitative urine testing (positive vs negative result). Positive results for illicit drugs were assessed separately (opioids, cocaine, THC, benzodiazepines, amphetamines, and atypical antipsychotics).
Readiness to Quit Smoking	up to 12 weeks	The Readiness to Quit Ladder was administered to participants at each of their in-person study visits, for a total of 4 data collections. Participants were asked to indicate their readiness to quit smoking on a scale ranging from 0 (I have no interest in quitting smoking) to 10 (I have already quit smoking).
Number of Participants That Moved in Stage of Change for Quitting Smoking	up to 12 weeks	Participants indicated one of the following stages of change at each of their four in-person study visits: Precontemplation (no plans to quit smoking), Contemplation (plans to quit smoking in the next 6 months), Preparation (plans to quit smoking in the next 30 days), Action (currently engaging in quitting smoking), or Maintenance (quit smoking more than 6 months ago). Data were quantified by determining the number of participants who moved towards quitting (i.e., moved up one or more stages), the number of participants who moved away from quitting (i.e., moved down one or more stages), and and the number of participants who remained in the same stage.