Heroin DependencePhase 2NCT00000326
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1
A Phase 2 study testing Heroin Dependence in people with Heroin Dependence and Opioid-Related Disorders, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Heroin Dependence, Opioid-Related Disorders
- What is being tested?
- Heroin Dependence
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1997to Aug 1997
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals must be currently opioid dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency.
Who cannot join
- Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Health Sciences Center
Denver, Colorado, 80206
About this study
Official title: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1(1)
The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen.
Read the detailed description
Alternate-day dosing with the 8mg buprenorphine-naloxone tablet is as safe and effective as daily dosing. Outcomes are improved when the total weekly dose provided during alternate-day dosing is equal to that given during daily dosing.
- Conditions
- Heroin Dependence, Opioid-Related Disorders
- Being tested
- Heroin Dependence
- Keywords
- Heroin Dependence
- Medical subject headings
- Heroin Dependence, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heroin DependenceDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug use
Retention
Subjective dose estimate
Observed withdrawal rating
Opioid agonist rating
Opioid antagonist rating
Pupil diameter
Compliance
Analog rating scale for drug effects
Drug effect characteristics
Dose order estimate-nurse
Dose order estimate-client
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 startApr 1997
- Primary completionAug 1997
- Study completionAug 1997
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 Heroin DependenceStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Leslie Amass, Ph.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000326
- Sponsor's protocol ID
- NIDA-11160-1
- Other IDs
- 1R01DA011160, R01-11160-1
- Status last verified
- May 2017
- First submitted
- 20 Sep 1999
- Last updated
- 4 May 2017
- Results posted
- No
Publications
(presented at ACNP 1997. Kamien, J.B., Mikulich, S.K., and Amass, L., Efficacy of the buprenorphine/naloxone tablet for daily vs. alternate-day opioid dependence treatment. Presented to the 1998 Meeting of the College on Problems of Drug Dependence.. Presented at ACNP 1997 and CPDD 1998.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1(1)
- ClinicalTrials.gov ID
- NCT00000326
- Acronym / sponsor ID
- NIDA-11160-1
- Conditions
- Heroin Dependence, Opioid-Related Disorders
- Keywords
- Heroin Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 1997
- Primary completion
- Aug 1997 (actual)
- Study completion
- Aug 1997 (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 assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen.
Detailed description
Alternate-day dosing with the 8mg buprenorphine-naloxone tablet is as safe and effective as daily dosing. Outcomes are improved when the total weekly dose provided during alternate-day dosing is equal to that given during daily dosing.
Study design
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals must be currently opioid dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency.
Key exclusion criteria (1 listed)
- Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.
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 |
|---|---|---|
| Heroin Dependence | Drug | – |
Primary outcome
Drug use
Retention
Subjective dose estimate
Observed withdrawal rating
Opioid agonist rating
Opioid antagonist rating
Pupil diameter
Compliance
Analog rating scale for drug effects
Drug effect characteristics
Dose order estimate-nurse
Dose order estimate-client
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Background(presented at ACNP 1997. Kamien, J.B., Mikulich, S.K., and Amass, L., Efficacy of the buprenorphine/naloxone tablet for daily vs. alternate-day opioid dependence treatment. Presented to the 1998 Meeting of the College on Problems of Drug Dependence.. Presented at ACNP 1997 and CPDD 1998.
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.
Leslie Amass, Ph.D. principal investigator
University of Colorado, Denver
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 Heroin Dependence in people with Heroin Dependence and Opioid-Related Disorders, run by University of Colorado, Denver 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: withdrawn, as of the sponsor's last update on 4 May 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 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 was withdrawn before enrolling participants, so there are no results.
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 use. The study lists 12 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 NCT00000326, 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 4 May 2017.