Nicotine Dependence Clinical Trial
Official title:
Developing a Smoking Cessation Intervention for Methadone Maintained Smokers
Verified date | September 2018 |
Source | Rutgers, The State University of New Jersey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to pilot and evaluate, in a randomized controlled trial, the
immediate and long-term effects of a newly developed, tailored, intensive smoking cessation
intervention among methadone maintained smokers and compared to a control condition
(facilitated referral to the NJ Quitline). The newly developed intervention is evidence
based, addresses the unique needs of methadone maintained smokers, is intensive, can be
tailored to the individual, and builds on the strengths as well as addresses the gaps in
previous treatments for methadone maintained smokers.
The investigators hypothesize that: (1) three months and six months after beginning
treatment, those in the tailored intervention condition will be more likely to be abstinent
from smoking than those in the control intervention condition (primary outcome); (2) there
will be a greater relapse rate in the control intervention condition between the three and
six month follow-up points than in the tailored intervention condition; (3) three and six
months after beginning treatment, those in the tailored intervention condition will have
better secondary smoking related outcomes (smoked fewer cigarettes per day in the past week,
be more ready to quit, have greater self-efficacy for quitting, experience less nicotine
dependence, and be more likely to have made a quit attempt) than those in the control
intervention condition; (4) three and six months after beginning treatment, those in the
tailored intervention condition will have better utilization of and adherence to smoking
cessation pharmacotherapy, better mental and physical health, less perceived stress, greater
social support, less drug and alcohol use, and greater involvement in drug and alcohol
treatment than those in the control intervention condition; and (5) the newly created
tailored intervention will be feasible and acceptable. .
Status | Completed |
Enrollment | 87 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Enrolled in methadone treatment for at least three months - Able to give informed consent - Willing and able to participate in all study activities - Smoked at least 100 cigarettes during their lifetime - Currently smoke every day or most days - Has access to a working telephone - Interested in participating in a smoking cessation intervention and quitting smoking within the next six months Exclusion Criteria: - Unable to speak English fluently - Took smoking cessation related medication or participated in smoking cessation counseling in the past three months - Pregnant or breastfeeding or planning on becoming pregnant or breastfeeding during the next six months |
Country | Name | City | State |
---|---|---|---|
United States | Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Rutgers, The State University of New Jersey | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Who Experienced Seven-day Point Prevalence Smoking Abstinence | Self-reported not smoking "even a puff" within the previous seven days, and exhaled carbon monoxide reading of <8 parts per million. | during the previous seven days at three months post baseline | |
Secondary | Median Number of Cigarettes Participants Smoked Per Day During the Past Week | Self-reported, median number of cigarettes per day during the previous seven days | during the previous seven days at three months post baseline | |
Secondary | Number of Participants Who Experienced Any Quit Attempts Since Baseline | Self-reported, smoke free for 24 hours or more since baseline (yes/no) | During the period between baseline and three months post enrollment | |
Secondary | Number of Participants Who Experienced Seven-day Point Prevalence of Smoking Abstinence | Self-reported not smoking "even a puff" within the previous seven days, and exhaled carbon monoxide reading of <8 parts per million. | during the previous seven days at six months post baseline | |
Secondary | Median Number of Cigarettes Smoked Per Day During the Past Week | Self-reported, median number of cigarettes per day during the previous seven days | during the previous seven days at six months post baseline | |
Secondary | Number of Participants Who Experienced Any Quit Attempts Since Enrollment | Self-reported, smoke free for 24 hours or more since baseline (yes/no) | during the period between baseline and six months post-enrollment |
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