Smoking Cessation Treatment for Methadone Maintenance Patients

May 4, 2021 updated by: Albert Einstein College of Medicine
Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Albert Einstein College of Medicine of Yeshiva University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 or older
  • English speaking
  • Smoked at least 100 cigarettes/lifetime
  • Smokes 5 or more cigarettes per day
  • Interested in quitting smoking (preparation or contemplation state of change)
  • Enrolled in Einstein/Montefiore methadone program for 3 or more months
  • Stable methadone dose for 2 weeks
  • Agree to use contraception throughout the trial (among women with reproductive potential)
  • Willing to participate in all study components
  • Able to provide informed consent

Exclusion Criteria:

  • Serious or unstable HIV/AIDS, liver, cardiovascular, or pulmonary disease
  • Psychiatric instability
  • Women who are pregnant, breastfeeding, or contemplating pregnancy
  • Creatinine clearance less than 30 mL/min

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Varenicline
Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Drug: Varenicline
Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
Other Names:
  • Chantix
Placebo Comparator: Placebo
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Drug: Placebo
Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
Other Names:
  • Matched capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.
Time Frame: Week 24
Week 24
Number of Counseling Visits Completed
Time Frame: End of 12 week intervention period
Participants were offered 5 counseling visits at weeks 0, 2, 4, 8, 12.
End of 12 week intervention period
Number of Study Visits Completed
Time Frame: 24 weeks
Mean number of study visit completed out of a possible total of 6 study visits at weeks 0, 2, 4, 8, 12 and 24.
24 weeks
7-day Point Prevalence Abstinence at 12 Weeks as Verified by Salivary Cotinine.
Time Frame: Weeks 2, 4, 8, 12, and 24
Threshold of salivary cotinine ≤ 15 ng/ml was prespecified. Salivary cotinine was measured among participants who self-reported 7-day point prevalence abstinence using a semi-quantitative assay (Nymox NicAlert™).
Weeks 2, 4, 8, 12, and 24
Number of Cigarettes Smoked Per Day
Time Frame: Weeks 2, 4, 8, 12, and 24
Weeks 2, 4, 8, 12, and 24
Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours
Time Frame: Weeks 2, 4, 8, 12, and 24
Weeks 2, 4, 8, 12, and 24
Confidence in Quitting Smoking (1-10 Scale)
Time Frame: Weeks 2, 4, 8, 12, and 24
Confidence of quitting smoking measure on a scale of 1-10 (10= high levels of quit confidence).
Weeks 2, 4, 8, 12, and 24
Importance of Quitting Smoking (1-10 Scale)
Time Frame: Weeks 2, 4, 8, 12, and 24
Importance of quitting smoking measured on a scale of 1-10 (10=high levels of quit importance).
Weeks 2, 4, 8, 12, and 24
Adverse Medication Effects
Time Frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory
Time Frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale
Time Frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview
Time Frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview
Time Frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview
Time Frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
over the intervention period (measured at weeks 2, 4, 8, 12, and 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Albert Einstein College of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Research Resources (NCRR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shadi Nahvi, M.D., M.S., Albert Einstein College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2008-537
  • UL1RR025750 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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