Drug AbusePhase 4CASANCT00685620
Reinforcement-Based Treatment and Abstinence-Contingent Housing for Drug Abusers
A Phase 4 study testing Reinforcement Based Treatment in people with Drug Abuse, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Purpose of the project is to examine the effectiveness of Reinforcement-Based Treatment (RBT) on drug abuse and psychosocial outcomes of iner city opiate abusers who have recently completed a brief detoxification. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Abuse
- What is being tested?
- Reinforcement Based Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 463 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Feb 2007
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- opiate dependent agree to live in recovery housing
Who cannot join
- acute psychiatric disorder pregnant over 65
Trial locations and contacts
1 site in 1 country.
About this study
Purpose of the project is to examine the effectiveness of Reinforcement-Based Treatment (RBT) on drug abuse and psychosocial outcomes of iner city opiate abusers who have recently completed a brief detoxification.
Read the detailed description
Participants are randomized into one of 3-groups: 1) those receiving intensive behavioral therapy plus abstinence-contingent housing, 2) those receiving recovery housing alone, and 3) those receiving standard care (referrals to community providers). For the two groups receiving recovery housing, rent payment is provided for a period of 3 months, as long as the participant remains drug-free.
- Conditions
- Drug Abuse
- Being tested
- Reinforcement Based Treatment
- 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.
Reinforcement Based TreatmentBehavioural
3 group random assignment to receive standard care, recovery housing alone, or recovery housing plus behavioral treatment
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | Standard care following detoxification |
| Group 2 | Active comparator | Recovery housing following detoxification Receives: Behavioral: Reinforcement Based Treatment |
| Group 3 | Experimental | Recovery housing plus counseling Receives: Behavioral: Reinforcement Based Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug abstinence at follow-up
Measured: 1, 3 and 6 months
Secondary outcomes (1)
Rates of employment
Measured: 1, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startAug 2002
- Primary completionFeb 2007
- Study completionFeb 2007
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 Drug 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Maxine Stitzer, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685620
- Sponsor's protocol ID
- BPR010213-01
- Acronym
- CASA
- Status last verified
- May 2008
- First submitted
- 23 May 2008
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Tuten M, DeFulio A, Jones HE, Stitzer M. Abstinence-contingent recovery housing and reinforcement-based treatment following opioid detoxification. Addiction. 2012 May;107(5):973-82. doi: 10.1111/j.1360-0443.2011.03750.x. Epub 2012 Feb 28.
PubMed 22151478
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reinforcement-Based Treatment and Abstinence-Contingent Housing for Drug Abusers
- ClinicalTrials.gov ID
- NCT00685620
- Acronym / sponsor ID
- CASA / BPR010213-01
- Conditions
- Drug Abuse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Aug 2002
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 28 May 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.
Purpose of the project is to examine the effectiveness of Reinforcement-Based Treatment (RBT) on drug abuse and psychosocial outcomes of iner city opiate abusers who have recently completed a brief detoxification.
Detailed description
Participants are randomized into one of 3-groups: 1) those receiving intensive behavioral therapy plus abstinence-contingent housing, 2) those receiving recovery housing alone, and 3) those receiving standard care (referrals to community providers). For the two groups receiving recovery housing, rent payment is provided for a period of 3 months, as long as the participant remains drug-free.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –Standard care following detoxification |
| Group 2 | Active comparator | Behavioral: Reinforcement Based TreatmentRecovery housing following detoxification |
| Group 3 | Experimental | Behavioral: Reinforcement Based TreatmentRecovery housing plus counseling |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- opiate dependent agree to live in recovery housing
Key exclusion criteria (1 listed)
- acute psychiatric disorder pregnant over 65
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 |
|---|---|---|
| Reinforcement Based Treatment3 group random assignment to receive standard care, recovery housing alone, or recovery housing plus behavioral treatment | Behavioural | Group 2, Group 3 |
Primary outcome
Drug abstinence at follow-up
Time frame: 1, 3 and 6 months
1 secondary outcome
Rates of employment
Time frame: 1, 3, and 6 months
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 11 Jan 2017.
- Derived from this study: PubMed 22151478Tuten M, DeFulio A, Jones HE, Stitzer M. Abstinence-contingent recovery housing and reinforcement-based treatment following opioid detoxification. Addiction. 2012 May;107(5):973-82. doi: 10.1111/j.1360-0443.2011.03750.x. Epub 2012 Feb 28.
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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.
Maxine Stitzer, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reinforcement Based Treatment in people with Drug Abuse, run by National Institute on Drug Abuse (NIDA) 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 11 Jan 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Drug abstinence at follow-up (time frame: 1, 3 and 6 months). 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 NCT00685620, 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 11 Jan 2017.