Clinical trial NCT02854800: Smoking Cessation & Opioid Dependence Treatment Integration
Official title: Smoking Cessation & Opioid Dependence Treatment Integration: Does Timing Matter?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Smoking Cessation
Opioid Related Disorders
Keywords: varenicline
buprenorphine
Lead sponsor: West Virginia University
Sponsor class: OTHER
Collaborators: name: Pfizer
name: National Institute on Drug Abuse (NIDA)
First posted: 2016-08-03
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Participants in all 3 study arms were given the same intervention treatment. Arms differed only by the number of days they had been enrolled in an outpatient opioid dependence program.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Recruitment, Assignment to Treatment, and Retention Rates
timeFrame: up to 12 weeks
measure: Percentage of Days on Which Participants Experienced Each Reason for Attrition
timeFrame: up to 4 weeks
measure: Number of Study Days With Protocol Non-Adherence
timeFrame: up to 12 weeks
measure: Medication Acceptability for Completers
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Number of Participants With Cigarette Smoking Quit Attempts and Actual Quit
timeFrame: Up to 12 weeks
measure: Number of Study Days Until First Cigarette Quit Attempt
timeFrame: up to 12 weeks
measure: Cigarettes Smoked Per Day
timeFrame: up to 12 weeks
measure: Drug Withdrawal Ratings
timeFrame: up to 12 weeks
measure: Expired Air Carbon Monoxide
timeFrame: up to 12 weeks
measure: Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc)
timeFrame: up to 12 weeks
measure: Readiness to Quit Smoking
timeFrame: up to 12 weeks
measure: Number of Participants That Moved in Stage of Change for Quitting Smoking
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University Chestnut Ridge Center
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Melissa D Blank, PhD
role: PRINCIPAL_INVESTIGATOR
References: