Opioid DependencePhase 2NCT00344812
Opioid Maintenance Medications Comparison Study
A Phase 2 study testing LAAM. buprenorphine and methadone in people with Opioid Dependence, run by Johns Hopkins University at 1 site in United States.
Trial summary
A 17 week, double-blind, randomized, parallel group, four arm design outpatient study comparing LAAM, buprenorphine and two dose levels of methadone for the treatment of opioid dependence. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- LAAM. buprenorphine and methadone
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1996to Jun 1998
- Phase
- Phase 2
- 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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 21 to 55 years
- diagnosis of opioid dependence by criteria of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
- evidence of recent opioid use on toxicologic screening
Who cannot join
- serious medical or psychiatric illness requiring long-term medication
- positive pregnancy test
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral Pharmacology Research Unit; Johns Hopkins Bayview Campus
Baltimore, Maryland, 21224
About this study
A 17 week, double-blind, randomized, parallel group, four arm design outpatient study comparing LAAM, buprenorphine and two dose levels of methadone for the treatment of opioid dependence.
- Conditions
- Opioid Dependence
- Being tested
- LAAM. buprenorphine and methadone
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAAM. buprenorphine and methadoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Study retention
Drug use
Secondary outcomes (1)
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2006 (estimated)
- Study startJan 1996
- Study completionJun 1998
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 Opioid DependenceStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 220 participants
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Investigators
- Rolley E Johnson, PharmD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344812
- Sponsor's protocol ID
- BPR-95-07-24-03
- Status last verified
- Mar 2006
- First submitted
- 26 Jun 2006
- Last updated
- 27 Jun 2006
- Results posted
- No
Publications
Johnson RE, Chutuape MA, Strain EC, Walsh SL, Stitzer ML, Bigelow GE. A comparison of levomethadyl acetate, buprenorphine, and methadone for opioid dependence. N Engl J Med. 2000 Nov 2;343(18):1290-7. doi: 10.1056/NEJM200011023431802.
PubMed 11058673
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Maintenance Medications Comparison Study
- ClinicalTrials.gov ID
- NCT00344812
- Acronym / sponsor ID
- BPR-95-07-24-03
- Conditions
- Opioid Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jan 1996
- Study completion
- Jun 1998
- First posted
- 27 Jun 2006 (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.
A 17 week, double-blind, randomized, parallel group, four arm design outpatient study comparing LAAM, buprenorphine and two dose levels of methadone for the treatment of opioid dependence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 21 to 55 years
- diagnosis of opioid dependence by criteria of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
- evidence of recent opioid use on toxicologic screening
Key exclusion criteria (2 listed)
- serious medical or psychiatric illness requiring long-term medication
- positive pregnancy test
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 |
|---|---|---|
| LAAM. buprenorphine and methadone | Drug | – |
Primary outcome
Study retention
Drug use
1 secondary outcome
Safety
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 27 Jun 2006.
- Results publication: PubMed 11058673Johnson RE, Chutuape MA, Strain EC, Walsh SL, Stitzer ML, Bigelow GE. A comparison of levomethadyl acetate, buprenorphine, and methadone for opioid dependence. N Engl J Med. 2000 Nov 2;343(18):1290-7. doi: 10.1056/NEJM200011023431802.
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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.
Rolley E Johnson, PharmD 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 2 study testing LAAM. buprenorphine and methadone in people with Opioid Dependence, run by Johns Hopkins University 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 3 inclusion and 2 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 27 Jun 2006. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Study retention. The study lists 2 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 NCT00344812, 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 27 Jun 2006.