Smoking Cessation & Opioid Dependence Treatment Integration

NCT02854800

Last updated date
Study Location
West Virginia University Chestnut Ridge Center
Morgantown, West Virginia, 26505, United States
Contact
304-293-8341

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation, Opioid Related Disorders
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Smoking Cessation, Opioid Related DisordersSmoking Cessation & Opioid Dependence Treatment Integration
NCT02854800
  1. Morgantown, West Virginia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Smoking Cessation & Opioid Dependence Treatment Integration
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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  ICMJE
  • Smoking Cessation
  • Opioid Related Disorders
Intervention  ICMJE 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 21, 2020)
74
Original Estimated Enrollment  ICMJE
 (submitted: July 30, 2016)
80
Actual Study Completion Date  ICMJE April 10, 2017
Actual Primary Completion Date April 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02854800
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD:No
Responsible Party Melissa Blank, West Virginia University
Study Sponsor  ICMJE West Virginia University
Collaborators  ICMJE
  • Pfizer
  • National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator:Melissa D Blank, PhDWest Virginia University
PRS Account West Virginia University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP