Substance Use DisordersREAPNCT00252512
The Effect of a Contingency Management Intervention on Substance Use
A study testing Contingency Management in people with Substance Use Disorders, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Contingency management interventions involve providing a tangible reward for progress toward treatment goals. The purpose of this study is to determine whether a contingency management intervention added to usual care leads to improved attendance and decreased substance use in patients attending outpatient substance… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 332 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2007to Feb 2010
- 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
- veterans presenting for outpatient substance use disorders treatment with a diagnosis of alcohol, cocaine, amphetamine, or methamphetamine dependence
Who cannot join
- primary cannabis dependence
- primary opioid dependence
- severe psychiatric symptoms
- suicide risk
- positive history or screen for pathological gambling
- lacking transportation or living too far away to attend twice per week research appointments
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
About this study
Official title: Effectiveness of Contingency Management in VA Addictions Treatment
Contingency management interventions involve providing a tangible reward for progress toward treatment goals. The purpose of this study is to determine whether a contingency management intervention added to usual care leads to improved attendance and decreased substance use in patients attending outpatient substance use disorders treatment.
Read the detailed description
Design: This will be a randomized, controlled trial. 360 veterans presenting for specialty substance use disorders treatment at the Minneapolis VAMC and the VA Puget Sound Health Care System will be randomly assigned to 8 weeks of Usual Care or Usual Care plus Contingency Management. Minimal exclusion criteria include primary cannabis dependence, primary opioid dependence, screening positive for pathological gambling, serious psychiatric symptoms or suicide risk. Randomization will be stratified by site and primary substance use disorder (alcohol or stimulant). All participants will meet with a research assistant twice per week to submit urine drug and breath alcohol samples. Participants randomized to the contingency management interventions will have the opportunity to draw tokens (with replacement) from a bowl each time they submit negative urine drug and breath alcohol screens. The number of drawings allowed escalates with continuous weeks of negative screens or returns to baseline if screens are positive or missed. Half of the 500 tokens will result in social reinforcement ("Good Job!"). The remainder will earn a VA canteen voucher worth monetary value. Follow-up assessments occur 2, 6, and 12 months after enrollment into the study. Primary outcomes measures include number of days with negative urine drug and breath alcohol screens during the intervention phase, days of treatment attendance during the intervention phase, and percent days abstinent on the Timeline Follow-Back interview at follow-up assessments. Secondary outcomes include a brief assessment of employment, housing, legal, and psychiatric status, and administrative data on VA service utilization. A process evaluation and an economic analysis are included.
- Conditions
- Substance Use Disorders
- Being tested
- Contingency Management, Placebo
- Keywords
- Contingency management interventions, Substance use disorders treatment, Treatment effectiveness, Randomized clinical trial, Behavioral research
- 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.
Contingency ManagementBehavioural
Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value.
PlaceboOther
Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
| Study group | Role | What they receive |
|---|---|---|
| Contingency Management | Experimental | Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are negative, they receive a chance to draw tokens from a bowl. Some tokens are social reinforcement. Others have monetary value. Receives: Behavioral: Contingency Management |
| Placebo | Placebo comparator | Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Negative Breath Alcohol and Urine Drug Screens Out of Possible 16
Measured: 8 weeks
Secondary outcomes (5)
Psychiatric Status
Kessler Psychological Distress Scale (K10) - score range 10 to 50.
- score under 20 are likely to be well
- score 20-24 are likely to have mild psychological distress
- score 25-29 are likely to have moderate psychological distress
- score 30 and over are likely to have a severe psychological distress
Measured: 8 weeks, 6 months, 12 months
VHA Healthcare Service Utilization
Cost of total healthcare utilization for six month period between baseline and 6 month follow up and six month period between 6 month and 12 month follow up.
Measured: Baseline to 6 month follow up and 6 month follow up to 12 month follow up.
Housing
Number of participants reporting stable housing (owned or rented house, apartment or room)
Measured: 8 week, 6 month and 12 month follow-ups
Legal Status
Number of participants reporting detention or incarceration in the previous 30 days
Measured: 8 weeks, 6 month and 12 month follow ups
Employment Status
Number of participants identifying themselves as unemployed.
Measured: 8 week, 6 month and 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 posted11 Nov 2005 (estimated)
- Study startMay 2007
- Primary completionJan 2010
- Study completionFeb 2010
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 Use DisordersStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Hildi J. Hagedorn, PhD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252512
- Sponsor's protocol ID
- IIR 03-120
- Acronym
- REAP
- Status last verified
- Jul 2018
- First submitted
- 9 Nov 2005
- Last updated
- 16 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hagedorn HJ, Noorbaloochi S, Simon AB, Bangerter A, Stitzer ML, Stetler CB, Kivlahan D. Rewarding early abstinence in Veterans Health Administration addiction clinics. J Subst Abuse Treat. 2013 Jul;45(1):109-17. doi: 10.1016/j.jsat.2013.01.006. Epub 2013 Feb 28.
PubMed 23453480Hagedorn HJ, Stetler CB, Bangerter A, Noorbaloochi S, Stitzer ML, Kivlahan D. An implementation-focused process evaluation of an incentive intervention effectiveness trial in substance use disorders clinics at two Veterans Health Administration medical centers. Addict Sci Clin Pract. 2014 Jul 9;9(1):12. doi: 10.1186/1940-0640-9-12.
PubMed 25008457Hagedorn HJ, Noorbaloochi S, Bangerter A, Stitzer ML, Kivlahan D. Health care cost trajectories in the year prior to and following intake into Veterans Health Administration outpatient substance use disorders treatment. J Subst Abuse Treat. 2017 Aug;79:46-52. doi: 10.1016/j.jsat.2017.05.013. Epub 2017 May 25.
PubMed 28673526
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Contingency Management in VA Addictions Treatment
- ClinicalTrials.gov ID
- NCT00252512
- Acronym / sponsor ID
- REAP / IIR 03-120
- Conditions
- Substance Use Disorders
- Keywords
- Contingency management interventions, Substance use disorders treatment, Treatment effectiveness, Randomized clinical trial, Behavioral research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- May 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 11 Nov 2005 (estimated)
- Results
- Posted 29 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Contingency management interventions involve providing a tangible reward for progress toward treatment goals. The purpose of this study is to determine whether a contingency management intervention added to usual care leads to improved attendance and decreased substance use in patients attending outpatient substance use disorders treatment.
Detailed description
Design: This will be a randomized, controlled trial. 360 veterans presenting for specialty substance use disorders treatment at the Minneapolis VAMC and the VA Puget Sound Health Care System will be randomly assigned to 8 weeks of Usual Care or Usual Care plus Contingency Management. Minimal exclusion criteria include primary cannabis dependence, primary opioid dependence, screening positive for pathological gambling, serious psychiatric symptoms or suicide risk. Randomization will be stratified by site and primary substance use disorder (alcohol or stimulant). All participants will meet with a research assistant twice per week to submit urine drug and breath alcohol samples. Participants randomized to the contingency management interventions will have the opportunity to draw tokens (with replacement) from a bowl each time they submit negative urine drug and breath alcohol screens. The number of drawings allowed escalates with continuous weeks of negative screens or returns to baseline if screens are positive or missed. Half of the 500 tokens will result in social reinforcement ("Good Job!"). The remainder will earn a VA canteen voucher worth monetary value. Follow-up assessments occur 2, 6, and 12 months after enrollment into the study. Primary outcomes measures include number of days with negative urine drug and breath alcohol screens during the intervention phase, days of treatment attendance during the intervention phase, and percent days abstinent on the Timeline Follow-Back interview at follow-up assessments. Secondary outcomes include a brief assessment of employment, housing, legal, and psychiatric status, and administrative data on VA service utilization. A process evaluation and an economic analysis are included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingency Management | Experimental | Behavioral: Contingency ManagementParticipants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are negative, they receive a chance to draw tokens from a bowl. Some tokens are social reinforcement. Others have monetary value. |
| Placebo | Placebo comparator | Other: PlaceboParticipants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- veterans presenting for outpatient substance use disorders treatment with a diagnosis of alcohol, cocaine, amphetamine, or methamphetamine dependence
Key exclusion criteria (6 listed)
- primary cannabis dependence
- primary opioid dependence
- severe psychiatric symptoms
- suicide risk
- positive history or screen for pathological gambling
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 |
|---|---|---|
| Contingency ManagementParticipants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value. | Behavioural | Contingency Management |
| PlaceboParticipants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results. | Other | Placebo |
Primary outcome
Number of Negative Breath Alcohol and Urine Drug Screens Out of Possible 16
Time frame: 8 weeks
5 secondary outcomes
Psychiatric Status
Time frame: 8 weeks, 6 months, 12 months
VHA Healthcare Service Utilization
Time frame: Baseline to 6 month follow up and 6 month follow up to 12 month follow up.
Housing
Time frame: 8 week, 6 month and 12 month follow-ups
Legal Status
Time frame: 8 weeks, 6 month and 12 month follow ups
Employment Status
Time frame: 8 week, 6 month and 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 16 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23453480Hagedorn HJ, Noorbaloochi S, Simon AB, Bangerter A, Stitzer ML, Stetler CB, Kivlahan D. Rewarding early abstinence in Veterans Health Administration addiction clinics. J Subst Abuse Treat. 2013 Jul;45(1):109-17. doi: 10.1016/j.jsat.2013.01.006. Epub 2013 Feb 28.
- Results publication: PubMed 25008457Hagedorn HJ, Stetler CB, Bangerter A, Noorbaloochi S, Stitzer ML, Kivlahan D. An implementation-focused process evaluation of an incentive intervention effectiveness trial in substance use disorders clinics at two Veterans Health Administration medical centers. Addict Sci Clin Pract. 2014 Jul 9;9(1):12. doi: 10.1186/1940-0640-9-12.
- Results publication: PubMed 28673526Hagedorn HJ, Noorbaloochi S, Bangerter A, Stitzer ML, Kivlahan D. Health care cost trajectories in the year prior to and following intake into Veterans Health Administration outpatient substance use disorders treatment. J Subst Abuse Treat. 2017 Aug;79:46-52. doi: 10.1016/j.jsat.2017.05.013. Epub 2017 May 25.
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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.
Hildi J. Hagedorn, PhD principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management in people with Substance Use Disorders, run by VA Office of Research and Development at 2 sites 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 6 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 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2014). 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 Negative Breath Alcohol and Urine Drug Screens Out of Possible 16 (time frame: 8 weeks). 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 NCT00252512, 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 16 Aug 2018.