Opioid-Related DisordersPhase 2NCT00015028
Buprenorphine/Naloxone for Opiate-Dependence Treatment - 1
A Phase 2 study testing Buprenorphine/naloxone in people with Opioid-Related Disorders and Substance-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment. The developmental objective for this combination product is an expansion of therapeutic options for the treatment of opiate dependence. Read more about this study
- Who is it for?
- Ages 23 to 59 years
- Conditions the study is for
- Opioid-Related Disorders, Substance-Related Disorders
- What is being tested?
- Buprenorphine/naloxone
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1996to Jan 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 23 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-IV (Diagnostic and Statistical Manual of the American Psychiatric Association) diagnosis of current opiate dependence.
- Individuals seeking opiate-substitution pharmacotherapy for opiate dependence.
- Males and non-pregnant, non-nursing females, 18 to 59 years of age (inclusive).
- Individuals able to give informed consent and willing to comply with all study procedures (e.g., providing of urine samples under observation, completing questionnaires).
Who cannot join
- Any acute or chronic medical condition that would make participation in the study medically hazardous (e.g., acute hepatitis, unstable cardiovascular, hepatic, or renal disease, unstable diabetes, symptomatic AIDS; not HIV-seropositivity alone).
- Aspartate or alanine aminotransferase (AST, ALT) levels greater than three times the upper limit of normal.
- Individuals currently taking systemic anti-retroviral or anti-fungal therapy.
- Current dependence (by DSM-IV criteria) on any psychoactive substance other than opiates, caffeine, or nicotine.
- Current, primary, Axis I psychiatric diagnosis other than opiate, caffeine, or nicotine dependence.
- Females of childbearing potential who do not agree to use a medically acceptable method of birth control. Acceptable methods include
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- oral contraceptive,
- barrier (diaphragm or condom) - a spermicide is not required due to the possibility of local irritation and allergic type reactions, but are recommended for use,
- levonorgestrel implant,
- intrauterine progesterone contraceptive system,
- medroxyprogesterone acetate contraceptive injection, or
- complete abstinence.
- Enrollment in an opiate-substitution (i.e., methadone, levo-alpha-acetylmethadol) treatment program within 45 days of enrolling in the present study.
- Individuals having taken (licitly or illicitly) LAAM, methadone, or naltrexone within days of enrolling in the present study.
- Individuals having taken buprenorphine, other than as an analgesic, within 365 days of enrolling in the present study.
- Participation in an investigational drug or device study within 45 days of enrolling in the present study.
- Anyone, who in the opinion of site principal investigator, would not be expected to complete the first phase of the study protocol (e.g., due to pending incarceration or probable relocation from the clinic area).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CS1008A Efficacy/Safety Trial of Buprenorphine/Naloxone
The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment. The developmental objective for this combination product is an expansion of therapeutic options for the treatment of opiate dependence.
Read the detailed description
This multicenter pivotal clinical trial was comprised of two phases. The first phase, which was four weeks in length, was double-blind placebo controlled and was primarily used to evaluate the efficacy of buprenorphine/naloxone. The second phase, lasting 48 weeks, was primarily conducted to determine the safety of buprenorphine/naloxone.
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Craving
Drug use
HIV risk behaviors
Adverse events
Medical evaluation
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 startNov 1996
- Primary completionDec 1996
- Study completionJan 1997
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 2
- Primary purpose
- Treatment
- Enrolment
- 0 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Cincinnati MDRU
- Investigators
- Eugene Somoza, M.D., Ph.D., Principal investigator, Cincinnati MDRU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00015028
- Sponsor's protocol ID
- NIDA-5-0012-1
- Other IDs
- Y01-5-0012-1
- Status last verified
- Nov 1996
- First submitted
- 18 Apr 2001
- Last updated
- 16 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CS1008A Efficacy/Safety Trial of Buprenorphine/Naloxone
- ClinicalTrials.gov ID
- NCT00015028
- Acronym / sponsor ID
- NIDA-5-0012-1
- Keywords
- opioid dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 0 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- Cincinnati MDRU
- Study start
- Nov 1996
- Primary completion
- Dec 1996 (actual)
- Study completion
- Jan 1997 (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 to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment. The developmental objective for this combination product is an expansion of therapeutic options for the treatment of opiate dependence.
Detailed description
This multicenter pivotal clinical trial was comprised of two phases. The first phase, which was four weeks in length, was double-blind placebo controlled and was primarily used to evaluate the efficacy of buprenorphine/naloxone. The second phase, lasting 48 weeks, was primarily conducted to determine the safety of buprenorphine/naloxone.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 23 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- DSM-IV (Diagnostic and Statistical Manual of the American Psychiatric Association) diagnosis of current opiate dependence.
- Individuals seeking opiate-substitution pharmacotherapy for opiate dependence.
- Males and non-pregnant, non-nursing females, 18 to 59 years of age (inclusive).
- Individuals able to give informed consent and willing to comply with all study procedures (e.g., providing of urine samples under observation, completing questionnaires).
Key exclusion criteria (17 listed)
- Any acute or chronic medical condition that would make participation in the study medically hazardous (e.g., acute hepatitis, unstable cardiovascular, hepatic, or renal disease, unstable diabetes, symptomatic AIDS; not HIV-seropositivity alone).
- Aspartate or alanine aminotransferase (AST, ALT) levels greater than three times the upper limit of normal.
- Individuals currently taking systemic anti-retroviral or anti-fungal therapy.
- Current dependence (by DSM-IV criteria) on any psychoactive substance other than opiates, caffeine, or nicotine.
- Current, primary, Axis I psychiatric diagnosis other than opiate, caffeine, or nicotine 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 |
|---|---|---|
| Buprenorphine/naloxone | Drug | – |
Primary outcome
Craving
Drug use
HIV risk behaviors
Adverse events
Medical evaluation
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 16 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.
Eugene Somoza, M.D., Ph.D. principal investigator
Cincinnati MDRU
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 Buprenorphine/naloxone in people with Opioid-Related Disorders and Substance-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 4 inclusion and 17 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 16 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.
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?
Craving. The study lists 5 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 16 Jan 2017.