Cocaine-Related DisordersPhase 3NCT00000311
Combining Behavioral Treatment With Agonist Maintenance - 1
A Phase 3 study testing Buprenorphine and methadone in people with Cocaine-Related Disorders and Opioid-Related Disorders, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether the community reinforcement approach (CRA) plus contingency management (CM) is more effective overall than CRA only in reducing illicit opioid and cocaine use during agonist maintenance treatment and at 3 and 6 month follow-up after completion of study protocol, and to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cocaine-Related Disorders, Opioid-Related Disorders, Substance-Related Disorders
- What is being tested?
- Buprenorphine and methadone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1995to Feb 1999
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Please contact site for information.
Trial locations and contacts
1 site in 1 country.
United States1 site
APT Residential Services Division
New Haven, Connecticut, 06519
About this study
Official title: Combining Behavioral Treatment With Agonist Maintenance
The purpose of this study is to evaluate whether the community reinforcement approach (CRA) plus contingency management (CM) is more effective overall than CRA only in reducing illicit opioid and cocaine use during agonist maintenance treatment and at 3 and 6 month follow-up after completion of study protocol, and to compare the efficacy of maintenance on buprenorphine to methadone when maintenance is combined with CRA only or CRA plus CM.
- Being tested
- Buprenorphine, methadone
- Keywords
- Cocaine-Related Disorders, Opioid-Related Disorders, Substance-Related Disorders
- Medical subject headings
- Cocaine-Related Disorders, Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuprenorphineDrug
Medication and Behavioral
methadoneDrug
medication and behavioral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Methadone + CM (contingency management) Receives: Drug: methadone |
| 2 | Experimental | methadone + VC (voucher control) Receives: Drug: methadone |
| 3 | Experimental | Buprenorphine + CM Receives: Drug: Buprenorphine |
| 4 | Experimental | Buprenorphine + VC Receives: Drug: Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Measured: 24 weeks
Withdrawal symptoms
Opioid and cocaine use
Social and psychological functioning
AIDS risk behavior
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 1999 (estimated)
- Study startFeb 1995
- Primary completionFeb 1999
- Study completionFeb 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine-Related DisordersStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Investigators
- Richard Schottenfeld, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000311
- Sponsor's protocol ID
- NIDA-09413-1
- Other IDs
- R01DA009413, R01-09413-1
- Status last verified
- Jan 2018
- First submitted
- 20 Sep 1999
- Last updated
- 17 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Behavioral Treatment With Agonist Maintenance
- ClinicalTrials.gov ID
- NCT00000311
- Acronym / sponsor ID
- NIDA-09413-1
- Keywords
- Cocaine-Related Disorders, Opioid-Related Disorders, Substance-Related Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Feb 1995
- Primary completion
- Feb 1999 (actual)
- Study completion
- Feb 1999 (actual)
- First posted
- 21 Sep 1999 (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 purpose of this study is to evaluate whether the community reinforcement approach (CRA) plus contingency management (CM) is more effective overall than CRA only in reducing illicit opioid and cocaine use during agonist maintenance treatment and at 3 and 6 month follow-up after completion of study protocol, and to compare the efficacy of maintenance on buprenorphine to methadone when maintenance is combined with CRA only or CRA plus CM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: methadoneMethadone + CM (contingency management) |
| 2 | Experimental | Drug: methadonemethadone + VC (voucher control) |
| 3 | Experimental | Drug: BuprenorphineBuprenorphine + CM |
| 4 | Experimental | Drug: BuprenorphineBuprenorphine + VC |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| BuprenorphineMedication and Behavioral | Drug | 3, 4 |
| methadonemedication and behavioral | Drug | 1, 2 |
Primary outcome
Depression
Time frame: 24 weeks
Withdrawal symptoms
Opioid and cocaine use
Social and psychological functioning
AIDS risk behavior
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 17 Jan 2018.
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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.
Richard Schottenfeld, M.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Buprenorphine and methadone in people with Cocaine-Related Disorders and Opioid-Related Disorders, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Depression (time frame: 24 weeks). The study lists 5 primary outcomes in all. 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 17 Jan 2018.