Cocaine-Related DisordersPhase 3NCT00000216
Buprenorphine Maintenance for Cocaine Abusing Opioid Addicts - 1
A Phase 3 study testing Buprenorphine 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 compare the clinical efficacy of maintenance on low and high doses of buprenorphine with methadone for cocaine abusing opiate addicts. 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
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Jan 2005
- 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: Buprenorphine Maintenance for Cocaine Abusing Opioid Addicts
The purpose of this study is to compare the clinical efficacy of maintenance on low and high doses of buprenorphine with methadone for cocaine abusing opiate addicts.
- Being tested
- Buprenorphine
- Keywords
- Opioid-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
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
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 completionJan 2005
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 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
- Enrolment
- 0 participants
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
- NCT00000216
- Sponsor's protocol ID
- NIDA-06266-1
- Other IDs
- R01DA006266, R01-06266-1
- Status last verified
- Jun 2020
- First submitted
- 20 Sep 1999
- Last updated
- 29 Jun 2020
- Results posted
- No
Publications
Schottenfeld RS, Pakes JR, Oliveto A, Ziedonis D, Kosten TR. Buprenorphine vs methadone maintenance treatment for concurrent opioid dependence and cocaine abuse. Arch Gen Psychiatry. 1997 Aug;54(8):713-20. doi: 10.1001/archpsyc.1997.01830200041006.
PubMed 9283506
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buprenorphine Maintenance for Cocaine Abusing Opioid Addicts
- ClinicalTrials.gov ID
- NCT00000216
- Acronym / sponsor ID
- NIDA-06266-1
- Keywords
- Opioid-Related Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 0 participants
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study completion
- Jan 2005 (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 compare the clinical efficacy of maintenance on low and high doses of buprenorphine with methadone for cocaine abusing opiate addicts.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| Buprenorphine | Drug | – |
Primary outcome
Depression
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 29 Jun 2020.
- Background: PubMed 9283506Schottenfeld RS, Pakes JR, Oliveto A, Ziedonis D, Kosten TR. Buprenorphine vs methadone maintenance treatment for concurrent opioid dependence and cocaine abuse. Arch Gen Psychiatry. 1997 Aug;54(8):713-20. doi: 10.1001/archpsyc.1997.01830200041006.
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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 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 29 Jun 2020. 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. 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?
On the ClinicalTrials.gov record for NCT00000216, 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 29 Jun 2020.