Opioid-Related DisordersNCT00134888
Blockade Efficacy of Buprenorphine/Naloxone For Opioid Dependence
A study testing Buprenorphine/naloxone in people with Opioid-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Buprenorphine, a treatment for opioid dependence, can be mixed with naloxone, to limit abuse potential. The purpose of this study is to examine the effectiveness of buprenorphine/naloxone that is given at less than daily intervals, in order to prevent withdrawal symptoms associated with stopping opioid abuse. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Opioid-Related Disorders
- What is being tested?
- Buprenorphine/naloxone
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2000to Nov 2002
- Phase
- Interventional
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meets diagnostic criteria for opioid dependence
- Qualifies for opioid substitution treatment (e.g., methadone)
Who cannot join
- Significant psychiatric or physical disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University (BPRU) Bayview Campus
Baltimore, Maryland, 21224 6823
About this study
Official title: The Acute and Protracted Blockade Efficacy of Buprenorphine/Naloxone
Buprenorphine, a treatment for opioid dependence, can be mixed with naloxone, to limit abuse potential. The purpose of this study is to examine the effectiveness of buprenorphine/naloxone that is given at less than daily intervals, in order to prevent withdrawal symptoms associated with stopping opioid abuse.
Read the detailed description
Buprenorphine and naloxone are often combined to decrease withdrawal symptoms in opioid dependent individuals. Buprenorphine/naloxone is usually given daily to individuals who are attempting to stop opioid abuse; however, research suggests that individuals may be more inclined to take medication if it is given in less than daily intervals. The purpose of this study is to examine the opioid blockade effects of buprenorphine/naloxone that is administered in less than daily doses to opioid dependent individuals.
This study will last 11 weeks. Participants will stay in a residential research unit for the duration of the study. Participants will be randomly assigned to receive different doses of daily, sublingual buprenorphine/naloxone. After a minimum of 2 weeks on each dose, participants will undergo challenge sessions on each weekday for 1 week (Monday through Friday). Challenge sessions will consist of increasing doses of intramuscular hydromorphone. During the challenge session week, buprenorphine/naloxone will be given only on Monday; a placebo will be given the rest of the week. Challenge sessions will examine the blockade effects of buprenorphine/naloxone at 2, 26, 50, 74, and 98 hours after the last active dose of buprenorphine/naloxone.
- Conditions
- Opioid-Related Disorders
- Being tested
- Buprenorphine/naloxone
- Keywords
- Opioid Dependence
- 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.
Buprenorphine/naloxoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological effects
Measured: up to one day
drug effects (measured at Week 11)
Measured: up to one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2005 (estimated)
- Study startDec 2000
- Study completionNov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Related DisordersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Eric C. Strain, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134888
- Sponsor's protocol ID
- NIDA-08045-2
- Other IDs
- R01-08045-2, DPMC
- Status last verified
- Jul 2007
- First submitted
- 23 Aug 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- 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
- The Acute and Protracted Blockade Efficacy of Buprenorphine/Naloxone
- ClinicalTrials.gov ID
- NCT00134888
- Acronym / sponsor ID
- NIDA-08045-2
- Conditions
- Opioid-Related Disorders
- Keywords
- Opioid Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Dec 2000
- Study completion
- Nov 2002 (actual)
- First posted
- 25 Aug 2005 (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.
Buprenorphine, a treatment for opioid dependence, can be mixed with naloxone, to limit abuse potential. The purpose of this study is to examine the effectiveness of buprenorphine/naloxone that is given at less than daily intervals, in order to prevent withdrawal symptoms associated with stopping opioid abuse.
Detailed description
Buprenorphine and naloxone are often combined to decrease withdrawal symptoms in opioid dependent individuals. Buprenorphine/naloxone is usually given daily to individuals who are attempting to stop opioid abuse; however, research suggests that individuals may be more inclined to take medication if it is given in less than daily intervals. The purpose of this study is to examine the opioid blockade effects of buprenorphine/naloxone that is administered in less than daily doses to opioid dependent individuals.
This study will last 11 weeks. Participants will stay in a residential research unit for the duration of the study. Participants will be randomly assigned to receive different doses of daily, sublingual buprenorphine/naloxone. After a minimum of 2 weeks on each dose, participants will undergo challenge sessions on each weekday for 1 week (Monday through Friday). Challenge sessions will consist of increasing doses of intramuscular hydromorphone. During the challenge session week, buprenorphine/naloxone will be given only on Monday; a placebo will be given the rest of the week. Challenge sessions will examine the blockade effects of buprenorphine/naloxone at 2, 26, 50, 74, and 98 hours after the last active dose of buprenorphine/naloxone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Meets diagnostic criteria for opioid dependence
- Qualifies for opioid substitution treatment (e.g., methadone)
Key exclusion criteria (1 listed)
- Significant psychiatric or physical disorder
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 | – |
Primary outcome
Physiological effects
Time frame: up to one day
drug effects (measured at Week 11)
Time frame: up to one day
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.
Eric C. Strain, MD 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 study testing Buprenorphine/naloxone in people with Opioid-Related Disorders, run by National Institute on Drug Abuse (NIDA) 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 2 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 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.
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?
Physiological effects (time frame: up to one day). 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?
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.