Cigarette Smoking Among Patients Currently Receiving Methadone or Buprenorphine Treatment for Opioid DependencePhase 2NCT00718835
Incentive-based Smoking Cessation for Methadone Patients
A Phase 2 study testing incentive-based contingency management in people with Cigarette Smoking Among Patients Currently Receiving Methadone or Buprenorphine Treatment for Opioid Dependence, run by University of Vermont Medical Center at 1 site in United States.
Trial summary
The prevalence of cigarette smoking among patients receiving opioid agonist treatment, such as methadone or buprenorphine maintenance, is more than three-fold that of the general population and is associated with increased morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cigarette Smoking Among Patients Currently Receiving Methadone or Buprenorphine Treatment for Opioid Dependence
- What is being tested?
- incentive-based contingency management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For inclusion in the proposed study, subjects must report smoking 10 or more cigarettes per day and have smoked at least that amount for the past year. Subjects must be maintained on a stable methadone or buprenorphine dose for the month before study intake, with no evidence of regular illicit-drug abuse (<30% positive specimens for illicit drugs in the past 30 days).
Who cannot join
- Participants will be excluded if they are currently pregnant and/or nursing or if they report regular THC use and are unwilling to stop before beginning the study (THC use will confound CO values when we aim to monitor smoking status).
Trial locations and contacts
1 site in 1 country.
United States1 site
Substance Abuse Treatment Center, University of Vermont
Burlington, Vermont, 05401
About this study
The prevalence of cigarette smoking among patients receiving opioid agonist treatment, such as methadone or buprenorphine maintenance, is more than three-fold that of the general population and is associated with increased morbidity and mortality. The overarching goal of this project is to systematically develop a voucher-based contingency-management (CM) intervention for promoting initial and longer-term abstinence from cigarette smoking in patients receiving methadone or buprenorphine treatment for their opioid abuse.
Read the detailed description
The prevalence of cigarette smoking among patients receiving opioid agonist treatment, such as methadone or buprenorphine maintenance, is more than three-fold that of the general population and is associated with increased morbidity and mortality. Despite these statistics, little is known about how to effectively help opioid-maintained patients to quit smoking. We believe a treatment that successfully promotes smoking cessation in these patients would offer exciting potential for dissemination. First, these treatment modalities are uniquely situated to offer an ideal setting for implementing smoking-cessation interventions. Many patients achieve significant periods of stability and drug abstinence and remain engaged in treatment for long periods of time, which can promote the frequent and prolonged clinical contact to enable success with smoking cessation. Second, opioid treatment programs often adhere to a uniform set of state and federal regulations, which could support the dissemination of an effective intervention throughout clinics across the country. Therefore, the overarching goal of this Behavior Therapy Development project is to systematically develop a voucher-based contingency-management (CM) intervention for promoting initial and longer-term abstinence from cigarette smoking in patients receiving methadone or buprenorphine treatment for their opioid abuse. Our first aim is to develop a CM treatment that will promote initial smoking abstinence in these patients using an intensive but brief 2-week intervention (Study 1). Our second aim will then be to integrate procedures for establishing initial abstinence with those designed for maintaining abstinence with the overarching goal of promoting smoking cessation that is sustained after the incentive program is discontinued (Study 2).
- Being tested
- incentive-based contingency management
- Keywords
- smoking cessation, behavioral treatment, contingency management, opioid maintenance, methadone, buprenorphine
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incentive-based contingency managementBehavioural
Direct comparison of Contingent versus Noncontingent incentives in promoting abstinence from smoking among opioid-treatment patients. The biochemical measures of breath carbon monoxide levels and urinary cotinine are used to confirm smoking status. Participants receive voucher-based incentives either contingent upon demonstrating abstinence from recent smoking (Contingent condition) or independent of smoking status (Noncontingent control condition).
| Study group | Role | What they receive |
|---|---|---|
| Contingent Voucher condition | Active comparator | Subjects in this condition will receive a brief education intervention plus voucher-based incentives contingent on demonstrating objective evidence of recent smoking abstinence. Receives: Behavioral: incentive-based contingency management |
| Noncontingent control condition | Placebo comparator | Subjects assigned to this control condition will receive the brief education and vouchers delivered independent of smoking status and yoked to the schedule of voucher earnings in the Contingent Voucher condition. Receives: Behavioral: incentive-based contingency management |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent of subjects abstinent during the second week of the two-week monitoring period
Measured: continuously and at end of 2-week trial
Secondary outcomes (1)
mean days of continuous abstinence achieved during the 2-week abstinence monitoring period and mean number days abstinent (non-continuous)
Measured: continuously and at end of 2-week trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startJun 2007
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cigarette Smoking Among Patients Currently Receiving Methadone or Buprenorphine Treatment for Opioid 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Stacey C. Sigmon, University of Vermont Medical Center
- Investigators
- Stacey C. Sigmon, Ph.D., Principal investigator, University of Vermont, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00718835
- Sponsor's protocol ID
- R01DA019550
- Other IDs
- R01DA019550
- Status last verified
- Feb 2014
- First submitted
- 17 Jul 2008
- Last updated
- 21 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sigmon SC, Miller ME, Meyer AC, Saulsgiver K, Badger GJ, Heil SH, Higgins ST. Financial incentives to promote extended smoking abstinence in opioid-maintained patients: a randomized trial. Addiction. 2016 May;111(5):903-12. doi: 10.1111/add.13264. Epub 2016 Jan 23.
PubMed 26638126
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incentive-based Smoking Cessation for Methadone Patients
- ClinicalTrials.gov ID
- NCT00718835
- Acronym / sponsor ID
- R01DA019550
- Keywords
- smoking cessation, behavioral treatment, contingency management, opioid maintenance, methadone, buprenorphine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 21 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of cigarette smoking among patients receiving opioid agonist treatment, such as methadone or buprenorphine maintenance, is more than three-fold that of the general population and is associated with increased morbidity and mortality. The overarching goal of this project is to systematically develop a voucher-based contingency-management (CM) intervention for promoting initial and longer-term abstinence from cigarette smoking in patients receiving methadone or buprenorphine treatment for their opioid abuse.
Detailed description
The prevalence of cigarette smoking among patients receiving opioid agonist treatment, such as methadone or buprenorphine maintenance, is more than three-fold that of the general population and is associated with increased morbidity and mortality. Despite these statistics, little is known about how to effectively help opioid-maintained patients to quit smoking. We believe a treatment that successfully promotes smoking cessation in these patients would offer exciting potential for dissemination. First, these treatment modalities are uniquely situated to offer an ideal setting for implementing smoking-cessation interventions. Many patients achieve significant periods of stability and drug abstinence and remain engaged in treatment for long periods of time, which can promote the frequent and prolonged clinical contact to enable success with smoking cessation. Second, opioid treatment programs often adhere to a uniform set of state and federal regulations, which could support the dissemination of an effective intervention throughout clinics across the country. Therefore, the overarching goal of this Behavior Therapy Development project is to systematically develop a voucher-based contingency-management (CM) intervention for promoting initial and longer-term abstinence from cigarette smoking in patients receiving methadone or buprenorphine treatment for their opioid abuse. Our first aim is to develop a CM treatment that will promote initial smoking abstinence in these patients using an intensive but brief 2-week intervention (Study 1). Our second aim will then be to integrate procedures for establishing initial abstinence with those designed for maintaining abstinence with the overarching goal of promoting smoking cessation that is sustained after the incentive program is discontinued (Study 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingent Voucher condition | Active comparator | Behavioral: incentive-based contingency managementSubjects in this condition will receive a brief education intervention plus voucher-based incentives contingent on demonstrating objective evidence of recent smoking abstinence. |
| Noncontingent control condition | Placebo comparator | Behavioral: incentive-based contingency managementSubjects assigned to this control condition will receive the brief education and vouchers delivered independent of smoking status and yoked to the schedule of voucher earnings in the Contingent Voucher condition. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- For inclusion in the proposed study, subjects must report smoking 10 or more cigarettes per day and have smoked at least that amount for the past year. Subjects must be maintained on a stable methadone or buprenorphine dose for the month before study intake, with no evidence of regular illicit-drug abuse (<30% positive specimens for illicit drugs in the past 30 days).
Key exclusion criteria (1 listed)
- Participants will be excluded if they are currently pregnant and/or nursing or if they report regular THC use and are unwilling to stop before beginning the study (THC use will confound CO values when we aim to monitor smoking status).
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 |
|---|---|---|
| incentive-based contingency managementDirect comparison of Contingent versus Noncontingent incentives in promoting abstinence from smoking among opioid-treatment patients. The biochemical measures of breath carbon monoxide levels and urinary cotinine are used to confirm smoking status. Participants receive voucher-based incentives either contingent upon demonstrating abstinence from recent smoking (Contingent condition) or independent of smoking status (Noncontingent control condition). | Behavioural | Contingent Voucher condition, Noncontingent control condition |
Primary outcome
percent of subjects abstinent during the second week of the two-week monitoring period
Time frame: continuously and at end of 2-week trial
1 secondary outcome
mean days of continuous abstinence achieved during the 2-week abstinence monitoring period and mean number days abstinent (non-continuous)
Time frame: continuously and at end of 2-week trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2014.
- Derived from this study: PubMed 26638126Sigmon SC, Miller ME, Meyer AC, Saulsgiver K, Badger GJ, Heil SH, Higgins ST. Financial incentives to promote extended smoking abstinence in opioid-maintained patients: a randomized trial. Addiction. 2016 May;111(5):903-12. doi: 10.1111/add.13264. Epub 2016 Jan 23.
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.
Stacey C. Sigmon, Ph.D. principal investigator
University of Vermont, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing incentive-based contingency management in people with Cigarette Smoking Among Patients Currently Receiving Methadone or Buprenorphine Treatment for Opioid Dependence, run by University of Vermont Medical Center 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 1 inclusion and 1 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 21 Feb 2014. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
percent of subjects abstinent during the second week of the two-week monitoring period (time frame: continuously and at end of 2-week trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00718835, which also lists 1 linked publication.
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 21 Feb 2014.