Nicotine DependencePhase 1NCT01393392
Developing a Smoking Cessation Intervention for Methadone Maintained Smokers
A Phase 1 study testing Intensive, tailored intervention and NJ Quitline Referral in people with Nicotine Dependence and Opiate Dependence, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nicotine Dependence, Opiate Dependence
- What is being tested?
- Intensive, tailored intervention and NJ Quitline Referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to May 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
About this study
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. .
Read the detailed description
Most individuals in methadone maintenance treatment are tobacco smokers. Also, people in methadone treatment are more likely to experience the health issues related to smoking than the general population. Yet, research has found that smokers receiving methadone treatment are interested in quitting and receiving tobacco cessation treatment, and people in drug treatment who quit smoking are less likely to use drugs.
To better help methadone maintained smokers quit smoking and prevent them from starting smoking again, we want to evaluate the effects of a new smoking cessation counseling intervention, designed for methadone maintained smokers as compared to a smoking cessation counseling intervention used with the general population.
Eligible participants will:
- Be English speaking (i.e., able to participate in counseling sessions in English and to complete study interviews in English);
- Be enrolled in methadone treatment for at least three months;
- Be able to give informed consent;
- Be willing and able to participate in all study activities;
- Not have taken smoking cessation related medication or participated in smoking cessation counseling in the past six months;
- Have smoked at least 100 cigarettes during their lifetime and currently smoke every day or most days;
- Not currently be pregnant or breastfeeding or plan on getting pregnant or breastfeeding during the next six months;
- Have access to a working telephone; and,
- Be interested in participating in a smoking cessation intervention and quitting smoking within the next six months.
Participants will be randomly assigned to receive either a smoking cessation intervention tailored for methadone maintained smokers or a referral to a smoking cessation program available to the general population (NJ Quitline). Participants assigned to receive the tailored intervention, will participate in approximately eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the participant's methadone clinic. Treatment needs will be assessed during the first session and the intervention will be tailored to participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them.
Study staff will contact the NJ Quitline for participants assigned to the control condition, and a counselor from the Quitline will call them.
Regardless of treatment assignment, participants will be asked to provide a urine sample for a drug test and pregnancy test (for women) and complete an interview, using a computer or face-to-face, before beginning treatment or receiving the NJ Quitline referral and three months and six months after study enrollment.Each interview will take approximately 45 minutes to one hour to complete.
Participants will receive a $20 gift card for completing each research visit (i.e., computer or face-to-face interview), but will not be reimbursed for counseling visits.
- Conditions
- Nicotine Dependence, Opiate Dependence
- Being tested
- Intensive, tailored intervention, NJ Quitline Referral
- Keywords
- smoking cessation, methadone treatment, nicotine addiction, drug treatment, drug addiction, tobacco dependence
- Medical subject headings
- Tobacco Use Disorder, Opioid-Related Disorders, Smoking Cessation, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive, tailored interventionBehavioural
Also called Smokers in Methadone Treatment Intervention, IMB Model Based Smoking Cessation Intervention
Eight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided.
NJ Quitline ReferralBehavioural
Also called Standard of Care Smoking Cessation Intervention, General Population Smoking Cessation Intervention
Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit).
| Study group | Role | What they receive |
|---|---|---|
| Intensive, tailored intervention | Experimental | Participants in the intensive intervention condition will receive eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the methadone clinic. Participant treatment needs will be assessed during the first session and the intervention will be tailored to the participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them. Receives: Behavioral: Intensive, tailored intervention |
| Control Intervention | Active comparator | Participants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants. Receives: Behavioral: NJ Quitline Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during the previous seven days at three months post baseline
Secondary outcomes (5)
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
Measured: during the previous seven days at three months post baseline
Number of Participants Who Experienced Any Quit Attempts Since Baseline
Self-reported, smoke free for 24 hours or more since baseline (yes/no)
Measured: During the period between baseline and three months post enrollment
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.
Measured: during the previous seven days at six months post baseline
Median Number of Cigarettes Smoked Per Day During the Past Week
Self-reported, median number of cigarettes per day during the previous seven days
Measured: during the previous seven days at six months post baseline
Number of Participants Who Experienced Any Quit Attempts Since Enrollment
Self-reported, smoke free for 24 hours or more since baseline (yes/no)
Measured: during the period between baseline and six months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Nina A. Copperman, Psy. D., Rutgers, The State University of New Jersey
- Investigators
- Nina Cooperman, Psy.D., Principal investigator, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393392
- Sponsor's protocol ID
- K23DA025049
- Other IDs
- K23DA025049
- Status last verified
- Sep 2018
- First submitted
- 27 Jun 2011
- Last updated
- 6 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Smoking Cessation Intervention for Methadone Maintained Smokers
- ClinicalTrials.gov ID
- NCT01393392
- Acronym / sponsor ID
- K23DA025049
- Conditions
- Nicotine Dependence, Opiate Dependence
- Keywords
- smoking cessation, methadone treatment, nicotine addiction, drug treatment, drug addiction, tobacco dependence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 Jul 2011 (estimated)
- Results
- Posted 6 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. .
Detailed description
Most individuals in methadone maintenance treatment are tobacco smokers. Also, people in methadone treatment are more likely to experience the health issues related to smoking than the general population. Yet, research has found that smokers receiving methadone treatment are interested in quitting and receiving tobacco cessation treatment, and people in drug treatment who quit smoking are less likely to use drugs.
To better help methadone maintained smokers quit smoking and prevent them from starting smoking again, we want to evaluate the effects of a new smoking cessation counseling intervention, designed for methadone maintained smokers as compared to a smoking cessation counseling intervention used with the general population.
Eligible participants will:
- Be English speaking (i.e., able to participate in counseling sessions in English and to complete study interviews in English);
- Be enrolled in methadone treatment for at least three months;
- Be able to give informed consent;
- Be willing and able to participate in all study activities;
- Not have taken smoking cessation related medication or participated in smoking cessation counseling in the past six months;
- Have smoked at least 100 cigarettes during their lifetime and currently smoke every day or most days;
- Not currently be pregnant or breastfeeding or plan on getting pregnant or breastfeeding during the next six months;
- Have access to a working telephone; and,
- Be interested in participating in a smoking cessation intervention and quitting smoking within the next six months.
Participants will be randomly assigned to receive either a smoking cessation intervention tailored for methadone maintained smokers or a referral to a smoking cessation program available to the general population (NJ Quitline). Participants assigned to receive the tailored intervention, will participate in approximately eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the participant's methadone clinic. Treatment needs will be assessed during the first session and the intervention will be tailored to participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them.
Study staff will contact the NJ Quitline for participants assigned to the control condition, and a counselor from the Quitline will call them.
Regardless of treatment assignment, participants will be asked to provide a urine sample for a drug test and pregnancy test (for women) and complete an interview, using a computer or face-to-face, before beginning treatment or receiving the NJ Quitline referral and three months and six months after study enrollment.Each interview will take approximately 45 minutes to one hour to complete.
Participants will receive a $20 gift card for completing each research visit (i.e., computer or face-to-face interview), but will not be reimbursed for counseling visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive, tailored intervention | Experimental | Behavioral: Intensive, tailored interventionParticipants in the intensive intervention condition will receive eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the methadone clinic. Participant treatment needs will be assessed during the first session and the intervention will be tailored to the participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them. |
| Control Intervention | Active comparator | Behavioral: NJ Quitline ReferralParticipants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive, tailored interventionAlso: Smokers in Methadone Treatment Intervention, IMB Model Based Smoking Cessation InterventionEight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided. | Behavioural | Intensive, tailored intervention |
| NJ Quitline ReferralAlso: Standard of Care Smoking Cessation Intervention, General Population Smoking Cessation InterventionParticipants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit). | Behavioural | Control Intervention |
Primary outcome
Number of Participants Who Experienced Seven-day Point Prevalence Smoking Abstinence
Time frame: during the previous seven days at three months post baseline
Self-reported not smoking "even a puff" within the previous seven days, and exhaled carbon monoxide reading of <8 parts per million.
5 secondary outcomes
Median Number of Cigarettes Participants Smoked Per Day During the Past Week
Time frame: during the previous seven days at three months post baseline
Number of Participants Who Experienced Any Quit Attempts Since Baseline
Time frame: During the period between baseline and three months post enrollment
Number of Participants Who Experienced Seven-day Point Prevalence of Smoking Abstinence
Time frame: during the previous seven days at six months post baseline
Median Number of Cigarettes Smoked Per Day During the Past Week
Time frame: during the previous seven days at six months post baseline
Number of Participants Who Experienced Any Quit Attempts Since Enrollment
Time frame: during the period between baseline and six months post-enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Cooperman, Psy.D. principal investigator
Rutgers Robert Wood Johnson Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intensive, tailored intervention and NJ Quitline Referral in people with Nicotine Dependence and Opiate Dependence, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced Seven-day Point Prevalence Smoking Abstinence (time frame: during the previous seven days at three months post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.