Opioid-Related DisordersNCT00134914
Effects of Buprenorphine/Naloxone Administered in Different Ways For Treating Opioid Dependence
A study testing Buprenorphine in people with Opioid-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid-Related Disorders
- What is being tested?
- Buprenorphine
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1996to May 1998
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Currently opioid dependent
- In good health, as determined by a pre-participation medical examination
- Seeking and eligible for methadone maintenance or detoxification treatment
Who cannot join
- Significant medical or psychiatric illness, other than drug dependence
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: Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals
Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine. The purpose of this study is to examine the effects of buprenorphine/naloxone when given through different routes and at different doses.
Read the detailed description
Buprenorphine, a mixed agonist-antagonist opioid (or partial agonist), is a safe and effective treatment for opioid dependence. However, there is concern that buprenorphine may be abused due to its high abuse potential. A sublingual buprenorphine/naloxone combination tablet may reduce the risk of abuse associated with buprenorphine alone. The purpose of this study is to characterize the effects of buprenorphine/naloxone in opioid-dependent individuals.
This study will last 10 weeks. Participants will stay in a residential research unit, and will be maintained on oral hydromorphone (10 mg). During twice-weekly experimental sessions, participants will be randomly assigned to receive either sublingual tablets, intramuscular injections, or a placebo. The 15 conditions studied will include: sublingual or intramuscular buprenorphine/naloxone (1/0.25 mg, 2/0.5 mg, 4/1 mg, 8/2 mg, and 16/4 mg), 0.25 mg of intramuscular naloxone (antagonist control), 10 mg of intramuscular hydromorphone (agonist control), sublingual and intramuscular buprenorphine (8 mg), and placebo.
- Conditions
- Opioid-Related Disorders
- Being tested
- Buprenorphine
- Keywords
- opiate 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.
BuprenorphineDrug
single doses given by sublingual and parenteral routes
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid agonist rating
Measured: up to one day
opiate withdrawal
Measured: up to one day
physiologic measures
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 startAug 1996
- Primary completionApr 1998
- Study completionMay 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-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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 10 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
- NCT00134914
- Sponsor's protocol ID
- NIDA-08045-4
- Other IDs
- R01-08045-4, DPMC
- Status last verified
- Jul 2008
- First submitted
- 23 Aug 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Stoller KB, Bigelow GE, Walsh SL, Strain EC. Effects of buprenorphine/naloxone in opioid-dependent humans. Psychopharmacology (Berl). 2001 Mar;154(3):230-42. doi: 10.1007/s002130000637.
PubMed 11351930
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
- Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals
- ClinicalTrials.gov ID
- NCT00134914
- Acronym / sponsor ID
- NIDA-08045-4
- Conditions
- Opioid-Related Disorders
- Keywords
- opiate dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Aug 1996
- Primary completion
- Apr 1998 (actual)
- Study completion
- May 1998 (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 is a treatment for opioid dependence. Naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine. The purpose of this study is to examine the effects of buprenorphine/naloxone when given through different routes and at different doses.
Detailed description
Buprenorphine, a mixed agonist-antagonist opioid (or partial agonist), is a safe and effective treatment for opioid dependence. However, there is concern that buprenorphine may be abused due to its high abuse potential. A sublingual buprenorphine/naloxone combination tablet may reduce the risk of abuse associated with buprenorphine alone. The purpose of this study is to characterize the effects of buprenorphine/naloxone in opioid-dependent individuals.
This study will last 10 weeks. Participants will stay in a residential research unit, and will be maintained on oral hydromorphone (10 mg). During twice-weekly experimental sessions, participants will be randomly assigned to receive either sublingual tablets, intramuscular injections, or a placebo. The 15 conditions studied will include: sublingual or intramuscular buprenorphine/naloxone (1/0.25 mg, 2/0.5 mg, 4/1 mg, 8/2 mg, and 16/4 mg), 0.25 mg of intramuscular naloxone (antagonist control), 10 mg of intramuscular hydromorphone (agonist control), sublingual and intramuscular buprenorphine (8 mg), and placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Currently opioid dependent
- In good health, as determined by a pre-participation medical examination
- Seeking and eligible for methadone maintenance or detoxification treatment
Key exclusion criteria (1 listed)
- Significant medical or psychiatric illness, other than drug dependence
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 |
|---|---|---|
| Buprenorphinesingle doses given by sublingual and parenteral routes | Drug | – |
Primary outcome
Opioid agonist rating
Time frame: up to one day
opiate withdrawal
Time frame: up to one day
physiologic measures
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.
- Results publication: PubMed 11351930Stoller KB, Bigelow GE, Walsh SL, Strain EC. Effects of buprenorphine/naloxone in opioid-dependent humans. Psychopharmacology (Berl). 2001 Mar;154(3):230-42. doi: 10.1007/s002130000637.
Related trials for Opioid-Related Disorders
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Active, not recruiting
EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy
Substance Use Disorders, Opioid Use Disorder, Severe
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 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 3 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?
Opioid agonist rating (time frame: up to one day). The study lists 3 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 NCT00134914, 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 12 Jan 2017.