Smoking Cessation & Opioid Dependence Treatment Integration

• ClinicalTrials.gov Identifier: NCT02854800
• Recruitment Status: Completed
• First Posted: August 3, 2016
• Results First Posted: August 5, 2020
• Last Update Posted: August 14, 2020
• Sponsor: West Virginia University
• Collaborators: Pfizer; National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Melissa Blank, West Virginia University

Tracking Information

• First Submitted Date: July 22, 2016
• First Posted Date: August 3, 2016
• Results First Submitted Date: July 2, 2020
• Results First Posted Date: August 5, 2020
• Last Update Posted Date: August 14, 2020
• Actual Study Start Date: July 8, 2016
• Actual Primary Completion Date: April 10, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 21, 2020)

• Recruitment, Assignment to Treatment, and Retention Rates [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

Original Primary Outcome Measures (submitted: July 30, 2016)

Cigarette smoking quit rates [ Time Frame: up to 12 weeks ]

Assessed by mobile questionnaire reports and verified by expired air carbon monoxide (cigarette smoking)

Current Secondary Outcome Measures (submitted: July 21, 2020)

• Number of Participants With Cigarette Smoking Quit Attempts and Actual Quit [ Time Frame: 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).
• Number of Study Days Until First Cigarette Quit Attempt [ Time Frame: 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.
• Cigarettes Smoked Per Day [ Time Frame: 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.
• Drug Withdrawal Ratings [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

Original Secondary Outcome Measures (submitted: July 30, 2016)

• Relapse rates for all drugs (cigarettes, opioid, other illicit substances) [ Time Frame: up to 12 weeks ]
  Verified by expired air carbon monoxide (cigarette smoking) or urine testing (all illicit drugs)
• Days until successful cigarette quit day [ Time Frame: up to 12 weeks ]
• Drug Withdrawal Ratings [ Time Frame: up to 12 weeks ]
  Ratings for craving, irritability, restless, alert, bored, calm/relaxed, able to focus, nervous, and other on a scale from 0-10
• Genetic markers in nicotinic and opiate-receptor regions [ Time Frame: baseline ]
• Medication side effect ratings [ Time Frame: up to 12 weeks ]
  Ratings of nausea, headache, sleep problems, gas/constipation, abnormal dreams, depressed mood, and drowsy from 0-10

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Smoking Cessation & Opioid Dependence Treatment Integration
• Official Title: Smoking Cessation & Opioid Dependence Treatment Integration: Does Timing Matter?
• 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.
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3

Study Design

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
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.

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Smoking Cessation
• Opioid Related Disorders

Intervention

Drug: varenicline

Participants followed the schedule of dosing that is specified on the label: 0.5 mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84).

Other Name: Chantix

Study Arms

• Experimental: Weekly Opioid Tx
  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
  Intervention: Drug: varenicline
• Experimental: Biweekly Opioid Tx
  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
  Intervention: Drug: varenicline
• Experimental: Monthly Opioid Tx
  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
  Intervention: Drug: varenicline

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 21, 2020): 74
• Original Estimated Enrollment (submitted: July 30, 2016): 80
• Actual Study Completion Date: April 10, 2017
• Actual Primary Completion Date: April 10, 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02854800
• Other Study ID Numbers: WestVirginiaU; NOT-DA-16-013 ( Other Identifier: National Institute on Drug Abuse )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Melissa Blank, West Virginia University
• Study Sponsor: West Virginia University

Collaborators

• Pfizer
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Melissa D Blank, PhD; West Virginia University

• PRS Account: West Virginia University
• Verification Date: August 2020