Opioid DependencePhase 4NCT00015340
Buprenorphine/Naloxone in the Treatment of Heroin Dependence - 14
A Phase 4 study testing Buprenorphine/naloxone in people with Opioid Dependence and Substance-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 5 sites in United States.
Trial summary
The purpose of this study is the safety and efficacy of Buprenorphine/Naloxone in the treatment of opioid dependence. A compassionate use study. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Dependence, Substance-Related Disorders
- What is being tested?
- Buprenorphine/naloxone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 582 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 1999to Sep 2001
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Completion of Cooperative Study 1008 A/B
Who cannot join
- Significant medical or psychiatric illness. Non-compliance with study procedures in the Cooperative Study 1008 A/B
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
VA Medical Center
Hines, Illinois, 60141
University of California
Los Angeles, California, 90095
New York VAMC
New York, New York, 10010
VA PUget Sound Helath Care System
Seattle, Washington, 98108
VA Medical Center
Tampa, Florida, 33612
About this study
Official title: Buprenorphine/Nx Treatment of Heroin Dependence-A Compassionate Use Study
The purpose of this study is the safety and efficacy of Buprenorphine/Naloxone in the treatment of opioid dependence. A compassionate use study.
Read the detailed description
The objective of this study is to provide follow-up compassionate use treatment and evaluate long term safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment for subjects who have completed Cooperative Study 1008 A and B.
- Conditions
- Opioid Dependence, Substance-Related Disorders
- Being tested
- Buprenorphine/naloxone
- Keywords
- Opioid Dependence
- Medical subject headings
- 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.
Buprenorphine/naloxoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine/Naloxone | Experimental | Not described Receives: Drug: Buprenorphine/naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craving
Retention
Opioid withdrawal
Subjective rating
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2001 (estimated)
- Study startAug 1999
- Primary completionAug 2001
- Study completionSep 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependenceStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- New York MDRU
- Investigators
- Paul Casadonte, M.D., Study chair, New York VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00015340
- Sponsor's protocol ID
- NIDA-5-0013-14
- Other IDs
- Y01-5-0013-14
- Status last verified
- Aug 2016
- First submitted
- 18 Apr 2001
- Last updated
- 12 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buprenorphine/Nx Treatment of Heroin Dependence-A Compassionate Use Study
- ClinicalTrials.gov ID
- NCT00015340
- Acronym / sponsor ID
- NIDA-5-0013-14
- Conditions
- Opioid Dependence, Substance-Related Disorders
- Keywords
- Opioid Dependence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- New York MDRU
- Study start
- Aug 1999
- Primary completion
- Aug 2001 (actual)
- Study completion
- Sep 2001 (actual)
- First posted
- 18 Apr 2001 (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 the safety and efficacy of Buprenorphine/Naloxone in the treatment of opioid dependence. A compassionate use study.
Detailed description
The objective of this study is to provide follow-up compassionate use treatment and evaluate long term safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment for subjects who have completed Cooperative Study 1008 A and B.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine/Naloxone | Experimental | Drug: Buprenorphine/naloxone |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Completion of Cooperative Study 1008 A/B
Key exclusion criteria (1 listed)
- Significant medical or psychiatric illness. Non-compliance with study procedures in the Cooperative Study 1008 A/B
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/naloxone | Drug | Buprenorphine/Naloxone |
Primary outcome
Craving
Retention
Opioid withdrawal
Subjective rating
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 12 Jan 2017.
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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.
Paul Casadonte, M.D. study chair
New York VAMC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Buprenorphine/naloxone in people with Opioid Dependence and Substance-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 5 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 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 12 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 5 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. 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?
Craving. The study lists 4 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 12 Jan 2017.