Substance AbuseSCMSUDNCT00807742
Contingency Management for Smoking in Substance Abusers
A study testing Nicotine Replacement Treatment (NRT), Brief Advice and Contingency Management in people with Substance Abuse, run by Brown University at 1 site in United States.
Trial summary
The aim of this study is to determine whether contingent reinforcement for smoking abstinence, compared to noncontingent reinforcement, increases the effectiveness of brief counseling and nicotine replacement on smoking abstinence of substance abusers in residential treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Nicotine Replacement Treatment (NRT), Brief Advice and Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Apr 2014
- Phase
- Interventional
- 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
- diagnosis of substance abuse or dependence by DSM-IV criteria
- in residential treatment at one particular agency
- currently smoking at least 10 cigarettes per day for the past 6 months
Who cannot join
- hallucinating or delusional or marked organic impairment (to the point of impairing ability to understand informed consent) according to medical records
- current use of nicotine replacement therapy, Zyban, or any other smoking cessation treatment
- medical exclusions for NRT: pregnant or nursing; treatment in the last 3 months for unstable angina, severe congestive heart failure, uncontrolled hypertension; lung cancer; supplemental oxygen; history of adverse reactions to NRT; allergies to adhesive; or any severe skin disease that requires treatment (e.g., psoriasis or eczema).
Trial locations and contacts
1 site in 1 country.
United States1 site
Brown University, Center for Alcohol and Addiction Studies
Providence, Rhode Island, 02903
About this study
Official title: Contingent Vouchers for Smoking in Substance Abusers as Adjunct to Nicotine Patch
The aim of this study is to determine whether contingent reinforcement for smoking abstinence, compared to noncontingent reinforcement, increases the effectiveness of brief counseling and nicotine replacement on smoking abstinence of substance abusers in residential treatment.
Read the detailed description
Substance abusers have a high prevalence and rate of smoking with little success in quitting, so stronger approaches are needed to encourage attempts to quit smoking.
The aim of this study is to determine whether contingent reinforcement for smoking abstinence (CM), compared to noncontingent reinforcement (NR), increases the effectiveness of brief counseling and nicotine replacement on smoking abstinence of substance abusers in residential treatment. The proposed study will be a 2-group design in which up to 274 substance abusers who smoke 10 or more cigarettes per day receive brief advice (4 sessions) and nicotine replacement (NRT) (8 weeks), and are randomized to 19 days of CM for smoking vs. a matched NR condition. The brief advice is adapted slightly for sobriety settings. Point-prevalence abstinence will be assessed at 1, 3, 6 and 12 months after starting treatment. Secondary aims evaluate effects of CM on substance use outcomes and potential mediators of effects on outcome, including within-treatment abstinence, motivation level and tolerance for smoking discomfort.
The significance is to add knowledge about the most effective ways to maximize smoking cessation among substance abusers, important given that no methods are known to work with this population.
- Conditions
- Substance Abuse
- Being tested
- Nicotine Replacement Treatment (NRT), Brief Advice, Contingency Management, Non-Contingent Reinforcement
- Keywords
- Contingency management for smoking for substance abusers, Contingency reinforcement for smoking abstinence, Contingency Management, Noncontingent Reinforcement
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Replacement Treatment (NRT)Drug
Also called Nicoderm CQ skin patch, Nicotine replacement therapy
Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief AdviceBehavioural
Also called Smoking counseling
Brief Advice (BA): Patients will receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
Contingency ManagementBehavioural
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Non-Contingent ReinforcementBehavioural
Controls for effects of receiving payments, providing daily breath samples for CO level, and degree of interaction between patient and research staff. NR will allow them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level attained.
| Study group | Role | What they receive |
|---|---|---|
| Contingency Management (CM) | Experimental | Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence. Receives: Drug: Nicotine Replacement Treatment (NRT); Behavioral: Brief Advice; Behavioral: Contingency Management |
| Noncontingent Reinforcement (NR) | Active comparator | Controls for effects of receiving payments, providing daily breath samples for CO level, and degree of interaction between patient and research staff. NR will allow them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level attained. Receives: Drug: Nicotine Replacement Treatment (NRT); Behavioral: Brief Advice; Behavioral: Non-Contingent Reinforcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Smoking Abstinent in Past 7 Days
7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.
Measured: 1-month follow-up
Number of Participants Smoking Abstinent in Past 7 Days
7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.
Measured: 3-month follow up
Number of Participants Smoking Abstinent in Past 7 Days
7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.
Measured: 6-month follow up
Number of Participants Smoking Abstinent in Past 7 Days
7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.
Measured: 12-month follow up
Average Number of Cigarettes Per Day
Measured: 1-month follow up
Average Number of Cigarettes Per Day
Measured: 3-month follow up
Average Number of Cigarettes Per Day
Timeline Followback interview assessing number of cigarettes on each day of each 3-month reporting period
Measured: 6-month follow up
Average Number of Cigarettes Per Day
Measured: 12-month follow up
Number of Participants With Relapse to Any Heavy Drinking
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Measured: 1-month follow up
Number of Participants With Relapse to Any Heavy Drinking
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Measured: 3-month follow up
Number of Participants With Relapse to Any Heavy Drinking
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Measured: 6-month follow up
Number of Participants With Relapse to Any Heavy Drinking
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Measured: 12-month follow up
Number of Participants With Relapse to Any Drug Use
Measured: 1-month follow up
Number of Participants With Relapse to Any Drug Use
Measured: 3-month follow up
Number of Participants With Relapse to Any Drug Use
Measured: 6-month follow up
Number of Participants With Relapse to Any Drug Use
Measured: 12-month follow up
Percent Smoking Days
Measured: 1-month follow up
Percent Smoking Days
Measured: 3-month follow up
Percent Smoking Days
Measured: 6-month follow up
Percent Smoking Days
Measured: 12-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionApr 2014
- Study completionApr 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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Damaris J. Rohsenow, Ph.D., Brown University
- Investigators
- Damaris Rohsenow, Ph.D., Principal investigator, Brown UniversityRosemarie Martin, Ph.D., Study director, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807742
- Sponsor's protocol ID
- 1R01DA023995-01
- Other IDs
- R01DA023995
- Acronym
- SCMSUD
- Status last verified
- Jan 2019
- First submitted
- 11 Dec 2008
- Last updated
- 23 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rohsenow DJ, Monti PM, Colby SM, Martin RA. Brief interventions for smoking cessation in alcoholic smokers. Alcohol Clin Exp Res. 2002 Dec;26(12):1950-1. doi: 10.1097/01.ALC.0000041006.59547.9A. No abstract available.
PubMed 12500132Rohsenow DJ, Martin RA, Tidey JW, Colby SM, Monti PM. Treating Smokers in Substance Treatment With Contingent Vouchers, Nicotine Replacement and Brief Advice Adapted for Sobriety Settings. J Subst Abuse Treat. 2017 Jan;72:72-79. doi: 10.1016/j.jsat.2016.08.012. Epub 2016 Aug 18.
PubMed 27658756Mackillop J, Murphy CM, Martin RA, Stojek M, Tidey JW, Colby SM, Rohsenow DJ. Predictive Validity of a Cigarette Purchase Task in a Randomized Controlled Trial of Contingent Vouchers for Smoking in Individuals With Substance Use Disorders. Nicotine Tob Res. 2016 May;18(5):531-7. doi: 10.1093/ntr/ntv233. Epub 2015 Oct 24.
PubMed 26498173
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contingent Vouchers for Smoking in Substance Abusers as Adjunct to Nicotine Patch
- ClinicalTrials.gov ID
- NCT00807742
- Acronym / sponsor ID
- SCMSUD / 1R01DA023995-01
- Conditions
- Substance Abuse
- Keywords
- Contingency management for smoking for substance abusers, Contingency reinforcement for smoking abstinence, Contingency Management, Noncontingent Reinforcement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2008
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 12 Dec 2008 (estimated)
- Results
- Posted 23 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine whether contingent reinforcement for smoking abstinence, compared to noncontingent reinforcement, increases the effectiveness of brief counseling and nicotine replacement on smoking abstinence of substance abusers in residential treatment.
Detailed description
Substance abusers have a high prevalence and rate of smoking with little success in quitting, so stronger approaches are needed to encourage attempts to quit smoking.
The aim of this study is to determine whether contingent reinforcement for smoking abstinence (CM), compared to noncontingent reinforcement (NR), increases the effectiveness of brief counseling and nicotine replacement on smoking abstinence of substance abusers in residential treatment. The proposed study will be a 2-group design in which up to 274 substance abusers who smoke 10 or more cigarettes per day receive brief advice (4 sessions) and nicotine replacement (NRT) (8 weeks), and are randomized to 19 days of CM for smoking vs. a matched NR condition. The brief advice is adapted slightly for sobriety settings. Point-prevalence abstinence will be assessed at 1, 3, 6 and 12 months after starting treatment. Secondary aims evaluate effects of CM on substance use outcomes and potential mediators of effects on outcome, including within-treatment abstinence, motivation level and tolerance for smoking discomfort.
The significance is to add knowledge about the most effective ways to maximize smoking cessation among substance abusers, important given that no methods are known to work with this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingency Management (CM) | Experimental | Drug: Nicotine Replacement Treatment (NRT), Behavioral: Brief Advice, Behavioral: Contingency ManagementCondition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence. |
| Noncontingent Reinforcement (NR) | Active comparator | Drug: Nicotine Replacement Treatment (NRT), Behavioral: Brief Advice, Behavioral: Non-Contingent ReinforcementControls for effects of receiving payments, providing daily breath samples for CO level, and degree of interaction between patient and research staff. NR will allow them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level attained. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of substance abuse or dependence by DSM-IV criteria
- in residential treatment at one particular agency
- currently smoking at least 10 cigarettes per day for the past 6 months
Key exclusion criteria (3 listed)
- hallucinating or delusional or marked organic impairment (to the point of impairing ability to understand informed consent) according to medical records
- current use of nicotine replacement therapy, Zyban, or any other smoking cessation treatment
- medical exclusions for NRT: pregnant or nursing; treatment in the last 3 months for unstable angina, severe congestive heart failure, uncontrolled hypertension; lung cancer; supplemental oxygen; history of adverse reactions to NRT; allergies to adhesive; or any severe skin disease that requires treatment (e.g., psoriasis or eczema).
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 |
|---|---|---|
| Nicotine Replacement Treatment (NRT)Also: Nicoderm CQ skin patch, Nicotine replacement therapyNicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all. | Drug | Contingency Management (CM), Noncontingent Reinforcement (NR) |
| Brief AdviceAlso: Smoking counselingBrief Advice (BA): Patients will receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all. | Behavioural | Contingency Management (CM), Noncontingent Reinforcement (NR) |
| Contingency ManagementCondition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence. | Behavioural | Contingency Management (CM) |
| Non-Contingent ReinforcementControls for effects of receiving payments, providing daily breath samples for CO level, and degree of interaction between patient and research staff. NR will allow them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level attained. | Behavioural | Noncontingent Reinforcement (NR) |
Primary outcome
Number of Participants Smoking Abstinent in Past 7 Days
Time frame: 1-month follow-up
7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.
Number of Participants Smoking Abstinent in Past 7 Days
Time frame: 3-month follow up
7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.
Number of Participants Smoking Abstinent in Past 7 Days
Time frame: 6-month follow up
7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.
Number of Participants Smoking Abstinent in Past 7 Days
Time frame: 12-month follow up
7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.
Average Number of Cigarettes Per Day
Time frame: 1-month follow up
Average Number of Cigarettes Per Day
Time frame: 3-month follow up
Average Number of Cigarettes Per Day
Time frame: 6-month follow up
Timeline Followback interview assessing number of cigarettes on each day of each 3-month reporting period
Average Number of Cigarettes Per Day
Time frame: 12-month follow up
Number of Participants With Relapse to Any Heavy Drinking
Time frame: 1-month follow up
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Number of Participants With Relapse to Any Heavy Drinking
Time frame: 3-month follow up
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Number of Participants With Relapse to Any Heavy Drinking
Time frame: 6-month follow up
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Number of Participants With Relapse to Any Heavy Drinking
Time frame: 12-month follow up
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Number of Participants With Relapse to Any Drug Use
Time frame: 1-month follow up
Number of Participants With Relapse to Any Drug Use
Time frame: 3-month follow up
Number of Participants With Relapse to Any Drug Use
Time frame: 6-month follow up
Number of Participants With Relapse to Any Drug Use
Time frame: 12-month follow up
Percent Smoking Days
Time frame: 1-month follow up
Percent Smoking Days
Time frame: 3-month follow up
Percent Smoking Days
Time frame: 6-month follow up
Percent Smoking Days
Time frame: 12-month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12500132Rohsenow DJ, Monti PM, Colby SM, Martin RA. Brief interventions for smoking cessation in alcoholic smokers. Alcohol Clin Exp Res. 2002 Dec;26(12):1950-1. doi: 10.1097/01.ALC.0000041006.59547.9A. No abstract available.
- Background: PubMed 27658756Rohsenow DJ, Martin RA, Tidey JW, Colby SM, Monti PM. Treating Smokers in Substance Treatment With Contingent Vouchers, Nicotine Replacement and Brief Advice Adapted for Sobriety Settings. J Subst Abuse Treat. 2017 Jan;72:72-79. doi: 10.1016/j.jsat.2016.08.012. Epub 2016 Aug 18.
- Results publication: PubMed 26498173Mackillop J, Murphy CM, Martin RA, Stojek M, Tidey JW, Colby SM, Rohsenow DJ. Predictive Validity of a Cigarette Purchase Task in a Randomized Controlled Trial of Contingent Vouchers for Smoking in Individuals With Substance Use Disorders. Nicotine Tob Res. 2016 May;18(5):531-7. doi: 10.1093/ntr/ntv233. Epub 2015 Oct 24.
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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.
Damaris Rohsenow, Ph.D. principal investigator
Brown University
Rosemarie Martin, Ph.D. study director
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine Replacement Treatment (NRT), Brief Advice and Contingency Management in people with Substance Abuse, run by Brown University 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 3 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 23 Jan 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2019). 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 Smoking Abstinent in Past 7 Days (time frame: 1-month follow-up). The study lists 20 primary outcomes in all. 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 NCT00807742, which also lists 3 linked publications.
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 23 Jan 2019.