Smoking Cessation & Opioid Dependence Treatment Integration

NCT02854800 | Completed Phase 2 Results

• 2 other identifiers: WestVirginiaUNOT-DA-16-013
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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).

Conditions

Smoking Cessation; Opioid Related Disorders

Keywords

varenicline; buprenorphine

Outcome Measures

Primary Outcomes (4)

• Recruitment, Assignment to Treatment, and Retention Rates

  For primary feasibility outcomes, recruitment, assignment to treatment, and retention rates were analyzed using descriptive statistics.

  up to 12 weeks

• Percentage of Days on Which Participants Experienced Each Reason for Attrition

  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.

  up to 4 weeks

• Number of Study Days With Protocol Non-Adherence

  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.

  up to 12 weeks

• Medication Acceptability for Completers

  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.

  up to 12 weeks

Secondary Outcomes (8)

• Number of Participants With Cigarette Smoking Quit Attempts and Actual Quit

  Up to 12 weeks

• Number of Study Days Until First Cigarette Quit Attempt

  up to 12 weeks

• Cigarettes Smoked Per Day

  up to 12 weeks

• Drug Withdrawal Ratings

  up to 12 weeks

• Expired Air Carbon Monoxide

  up to 12 weeks

Study Arms (3)

Weekly Opioid Tx

EXPERIMENTAL

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

Drug: varenicline

Biweekly Opioid Tx

EXPERIMENTAL

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

Drug: varenicline

Monthly Opioid Tx

EXPERIMENTAL

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

Drug: varenicline

Interventions

varenicline DRUG

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).

Also known as: Chantix

Biweekly Opioid Tx; Monthly Opioid Tx; Weekly Opioid Tx

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead
• Pfizer: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

West Virginia University Chestnut Ridge Center

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Opioid-Related Disorders

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Limitations and Caveats

Due to the study's pilot nature, the sample size is relatively small and statistical power is relatively low. High rates of participant dropout were observed, possibly due to medication side effects or the burden of daily assessments for 12 weeks.

Results Point of Contact

• Title: Dr. Melissa Blank
• Organization: West Virginia University

Melissa.Blank@mail.wvu.edu

304-293-8341

Study Officials

• Melissa D Blank, PhD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: August 3, 2016
• Study Start: July 8, 2016
• Primary Completion: April 10, 2017
• Study Completion: April 10, 2017
• Last Updated: August 14, 2020
• Results First Posted: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)