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A Trial of Directly Observed and Long-term Varenicline

Primary Purpose

Tobacco Use Disorder, Opioid-use Disorder

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Long-Term Varenicline
Short-Term Varenicline
Directly Observed Therapy
Self Administered Therapy
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring directly observed therapy, varenicline, long-term pharmacotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1) age ≥18 years old; 2) English or Spanish speaking (i.e., be able to participate in study interviews in English or Spanish); 3) current cigarette smoking (smoked at least 100 cigarettes/lifetime, smoking ≥ 5 cigarettes/day); 4) interest in quitting tobacco smoking; 5) receiving methadone or buprenorphine in the DoSA clinic one to six times weekly; 6) enrollment in a DoSA opioid treatment program ≥ 3 months; 7) stable methadone or buprenorphine dose for two weeks; 8) agreement to use contraception for the duration of the trial (among women with reproductive potential); 9) willingness to participate in all study components; and 10) ability to provide informed consent.

Exclusion Criteria:

1) serious or unstable disease, specifically: decompensated cirrhosis (INR≥ 1.7, albumin <2.7 g/dl or physical exam evidence of decompensated cirrhosis); severe cardiovascular disease (MI, PTCA, unstable angina, CABG, and/or serious arrhythmia in the previous 6 months); severe asthma or chronic obstructive pulmonary disease (requiring supplemental oxygen or hospitalization in past 6 months); HIV/AIDS (AIDS-defining illness or hospitalization in past 6 months); 2) creatinine clearance <30 mL/min; 3) history of seizure disorder; 4) women who are pregnant, breastfeeding, or contemplating pregnancy; 5) current suicidal ideation; 6) history of suicide attempt in the past year; 7) psychiatric hospitalization in the past year; 8) current DSM V criteria for major depressive episode, current bipolar disorder, or current psychotic disorder; 9) current DSM V criteria for alcohol use disorder; or 10) use of varenicline in the past 30 days.

Sites / Locations

  • Albert Einstein College of Medicine of Yeshiva UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Long-Term Varenicline

Short-Term Varenicline

Directly Observed Therapy

Self Administered Therapy

Arm Description

Participants will receive 24 weeks of varenicline at standard doses (0.5 mg/day for days 1 to 3, 0.5 mg twice daily for days 4 to 7, then 1 mg twice daily)

Participants will receive 12 weeks of varenicline at standard doses (0.5 mg/day for days 1 to 3, 0.5 mg twice daily for days 4 to 7, then 1 mg twice daily), followed by matching placebo twice daily through week 24.

Participants receiving directly observed therapy (DOT) will receive varenicline from opioid treatment program nurses at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.

Patients receiving varenicline self administered therapy (SAT) will self-administer all varenicline doses.

Outcomes

Primary Outcome Measures

Initial abstinence
Period of ≥ 24 hour self-reported abstinence during the intervention period
Time to lapse
First day on which subjects smoke, even a puff, after a period of initial abstinence
Time to relapse
First day of seven consecutive days of self-reported smoking after a period of initial abstinence

Secondary Outcome Measures

Durability of tobacco abstinence
CO-verified, 7-day point prevalence abstinence at week 28
Durability of tobacco abstinence
CO-verified, 7-day point prevalence abstinence at week 52
Cigarettes smoked per day
self reported number of cigarettes smoked per day
Nicotine dependence
Fagerstrom test of nicotine dependence
Quality of life
Medical Outcomes Study Short Form 12

Full Information

First Posted
November 28, 2017
Last Updated
December 28, 2022
Sponsor
Albert Einstein College of Medicine
Collaborators
National Institutes of Health (NIH), Pfizer, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03365362
Brief Title
A Trial of Directly Observed and Long-term Varenicline
Official Title
Achieving Smoking Cessation Milestones in Opioid Treatment Patients: a Randomized 2 x 2 Factorial Trial of Directly Observed and Long-term Varenicline
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2018 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Institutes of Health (NIH), Pfizer, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This 2 x 2 factorial, randomized, double-blind, placebo-controlled trial will test two interventions: directly observed medication therapy, and long-term therapy with varenicline among 450 smokers with opioid use disorder recruited from community-based, outpatient opioid treatment programs. The analytic strategy will evaluate the milestones in smoking cessation-achieving initial abstinence, preventing lapse and preventing relapse--necessary for long-term cessation, and evaluate theoretically-guided psychological and social factors and pharmacogenetic factors that influence these cessation processes.
Detailed Description
Tobacco use and tobacco-related disease are highly prevalent among persons with opioid use disorders (OUD). Unfortunately, traditional evidence-based smoking cessation interventions have yielded low rates of tobacco abstinence in this group. The majority of trials evaluating smoking cessation treatment interventions among persons with OUD have relied on short-term interventions that do not account for the unique challenges faced by these smokers, specifically, establishing initial abstinence, adhering to evidence-based cessation treatments, and maintaining abstinence once active treatments cease. Long-term smoking cessation medication treatment approaches have shown promise in promoting cessation and decreasing relapse among individuals without OUD, however the applicability of extended medication approaches to smokers with OUD may be limited by poor adherence to smoking cessation medications. Though adherence to cessation medication is strongly associated with cessation success, adherence is especially challenging for persons with OUD. Opioid treatment program-based directly observed therapy (DOT) interventions improve clinical outcomes in HIV and TB, and pilot data suggest that DOT varenicline is associated with increased smoking cessation medication adherence and may increase smoking cessation rates. In this 2 x 2 factorial, randomized, double-blind, placebo-controlled trial, the investigators will test two interventions: directly observed medication therapy, and long-term therapy with varenicline. The analytic strategy will evaluate the milestones in smoking cessation-achieving initial abstinence, preventing lapse and preventing relapse--necessary for long-term cessation, and evaluate theoretically-guided psychological and social factors and pharmacogenetic factors that influence these cessation processes. The investigators will recruit 450 smokers with OUD from community-based, outpatient opioid treatment programs and test the following specific aims: (1) to test the efficacy of directly observed varenicline therapy compared to self-administered varenicline therapy on smoking cessation milestones, (2) to test the efficacy of long-term varenicline compared to short-term varenicline on smoking cessation milestones, and (3) to understand the mechanism of smoking cessation by examining the impact of theory-guided psychological and social factors and of pharmacogenetic factors on cessation milestones.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder, Opioid-use Disorder
Keywords
directly observed therapy, varenicline, long-term pharmacotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Long-Term Varenicline
Arm Type
Experimental
Arm Description
Participants will receive 24 weeks of varenicline at standard doses (0.5 mg/day for days 1 to 3, 0.5 mg twice daily for days 4 to 7, then 1 mg twice daily)
Arm Title
Short-Term Varenicline
Arm Type
Active Comparator
Arm Description
Participants will receive 12 weeks of varenicline at standard doses (0.5 mg/day for days 1 to 3, 0.5 mg twice daily for days 4 to 7, then 1 mg twice daily), followed by matching placebo twice daily through week 24.
Arm Title
Directly Observed Therapy
Arm Type
Experimental
Arm Description
Participants receiving directly observed therapy (DOT) will receive varenicline from opioid treatment program nurses at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.
Arm Title
Self Administered Therapy
Arm Type
Active Comparator
Arm Description
Patients receiving varenicline self administered therapy (SAT) will self-administer all varenicline doses.
Intervention Type
Drug
Intervention Name(s)
Long-Term Varenicline
Other Intervention Name(s)
varenicline, chantix
Intervention Description
Varenicline tablet x 24 weeks
Intervention Type
Drug
Intervention Name(s)
Short-Term Varenicline
Other Intervention Name(s)
varenicline, chantix, placebo
Intervention Description
varenicline tablet for 12 weeks, followed by placebo tablet manufactured to mimic varenicline 1 mg tablet
Intervention Type
Behavioral
Intervention Name(s)
Directly Observed Therapy
Intervention Description
Varenicline doses are administered by opioid treatment program nurses
Intervention Type
Behavioral
Intervention Name(s)
Self Administered Therapy
Intervention Description
Varenicline doses are self-administered
Primary Outcome Measure Information:
Title
Initial abstinence
Description
Period of ≥ 24 hour self-reported abstinence during the intervention period
Time Frame
24 weeks
Title
Time to lapse
Description
First day on which subjects smoke, even a puff, after a period of initial abstinence
Time Frame
24 weeks
Title
Time to relapse
Description
First day of seven consecutive days of self-reported smoking after a period of initial abstinence
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Durability of tobacco abstinence
Description
CO-verified, 7-day point prevalence abstinence at week 28
Time Frame
week 28
Title
Durability of tobacco abstinence
Description
CO-verified, 7-day point prevalence abstinence at week 52
Time Frame
week 52
Title
Cigarettes smoked per day
Description
self reported number of cigarettes smoked per day
Time Frame
24 weeks
Title
Nicotine dependence
Description
Fagerstrom test of nicotine dependence
Time Frame
24 weeks
Title
Quality of life
Description
Medical Outcomes Study Short Form 12
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1) age ≥18 years old; 2) English or Spanish speaking (i.e., be able to participate in study interviews in English or Spanish); 3) current cigarette smoking (smoked at least 100 cigarettes/lifetime, smoking ≥ 5 cigarettes/day); 4) interest in quitting tobacco smoking; 5) receiving methadone or buprenorphine in the DoSA clinic one to six times weekly; 6) enrollment in a DoSA opioid treatment program ≥ 3 months; 7) stable methadone or buprenorphine dose for two weeks; 8) agreement to use contraception for the duration of the trial (among women with reproductive potential); 9) willingness to participate in all study components; and 10) ability to provide informed consent. Exclusion Criteria: 1) serious or unstable disease, specifically: decompensated cirrhosis (INR≥ 1.7, albumin <2.7 g/dl or physical exam evidence of decompensated cirrhosis); severe cardiovascular disease (MI, PTCA, unstable angina, CABG, and/or serious arrhythmia in the previous 6 months); severe asthma or chronic obstructive pulmonary disease (requiring supplemental oxygen or hospitalization in past 6 months); HIV/AIDS (AIDS-defining illness or hospitalization in past 6 months); 2) creatinine clearance <30 mL/min; 3) history of seizure disorder; 4) women who are pregnant, breastfeeding, or contemplating pregnancy; 5) current suicidal ideation; 6) history of suicide attempt in the past year; 7) psychiatric hospitalization in the past year; 8) current DSM V criteria for major depressive episode, current bipolar disorder, or current psychotic disorder; 9) current DSM V criteria for alcohol use disorder; or 10) use of varenicline in the past 30 days.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shadi Nahvi, MD, MS
Phone
718 920 5379
Email
snahvi@montefiore.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shadi Nahvi, MD, MS
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine of Yeshiva University
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shadi Nahvi, M.D., M.S.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Our final dataset will include: survey and laboratory data, including demographic, medical, tobacco, and other substance use-related information about all clinical trial subjects. The final dataset will be stripped of all personal identifiers.
IPD Sharing Time Frame
After data collection and cleaning is complete.
IPD Sharing Access Criteria
We will share data with qualified investigators whose research protocols have been approved by their institutions' Institutional Review Boards. Data will be made available to potential users under a NIDA-approved data-sharing agreement that ensures that: (1) data is used only for research purposes and does not identify individual participants; (2) data is handled in a secure and confidential way; and (3) data is destroyed or returned after analyses are completed.

Learn more about this trial

A Trial of Directly Observed and Long-term Varenicline

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