Heroin DependencePhase 3NCT00032955
Buprenorphine/Naloxone Versus Clonidine for Inpatient Opiate Detoxification - 1
A Phase 3 study testing Buprenorphine/naloxone in people with Heroin Dependence and Morphine Dependence, run by University of California, Los Angeles at 6 sites in United States.
Trial summary
The purpose of this study is to assess buprenorphine/naloxone versus clonidine for inpatient opiate detoxification. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Heroin Dependence, Morphine Dependence, Substance Withdrawal Syndrome
- What is being tested?
- Buprenorphine/naloxone
- How many people
- 163 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2001to Aug 2002
- Phase
- Phase 3
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Treatment-seeking males and non-pregnant and non-lactating females, 15 years and older, who fulfill DSM-IV criteria for opiate dependence, report experiencing symptoms of opiate withdrawal, are currently physically dependent on opioids, and are need of medical assistance for opioid withdrawal.
- Systolic blood pressure > or = 100mm Hg, and pulse > or = 56 bpm.
- Good general health or, in case of a medical/psychiatric condition needing ongoing treatment, under the care of a physician willing to continue patient's medical management and cooperate with the study physicians.
- Agreeable to and capable of signing the informed consent approved by an institutional review board and, if under the age of 18 (excluding emancipated minors), assent and concurrent consent from a parent or legal guardian.
- Use of one of the following acceptable methods of birth control by female patients of childbearing potential:
- oral contraceptives
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- barrier (diaphragm or cervical cap) with spermicide or condom
- intrauterine progesterone contraceptive system
- levonorgestrel implant
- medroxyprogesterone acetate contraceptive injection
- complete abstinence from sexual intercourse
Who cannot join
- Medical condition that would make participation, in the opinion of the study physician, medically hazardous (e.g., acute hepatitis, unstable cardiovascular, liver or renal disease);
- Clinically significant abnormalities in ECG.
- Known allergy or sensitivity to buprenorphine, naloxone, or clonidine.
- Receiving beta-blockers, calcium channel blockers, tricyclics, digitalis and other medications which may interact adversely with clonidine.
- Acute severe psychiatric condition in need of immediate treatment, or imminent suicide risk.
- Dependence on alcohol, benzodiazepines or other depressants, or stimulants, and requiring immediate medical attention.
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- Participation in an investigational drug study, including buprenorphine, within the past 30 days.
- Methadone or LAAM maintenance or detoxification within 30 days of enrollment.
- Pending legal action that could prohibit or interfere with participation.
- Unable to remain in area for duration of active phase of treatment.
- Females that are pregnant, lactating, or planning to become pregnant.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Maryhaven, Inc.
Columbus, Ohio, 43207
Self Help Addiction Rehabilitation (SHAR), Inc.
Detroit, Michigan, 48208
Phoenix House
New York, New York, 10023
The Center For Drug-Free Living
Orlando, Florida, 32801
Operation PAR, Inc.
Pinellas Park, Florida, 33781
Betty Ford Center
Rancho Mirage, California, 92270
About this study
Official title: Buprenorphine/Naloxone Versus Clonidine for Inpatient Opiate Detoxification
The purpose of this study is to assess buprenorphine/naloxone versus clonidine for inpatient opiate detoxification.
Read the detailed description
Patients randomized to the BUP/NX arm will receive daily doses for 13 days with sublingual administration of 2 mg buprenorphine/0.5 mg naloxone tablet(s) and/or an 8 mg buprenorphine/2.0 mg naloxone tablet(s). The starting dose on day 1 is 4 mg/1 mg BUP/NX with an additional 4 mg/1 mg, if needed, escalating in a step-wise manner to 16 mg/4 mg BUP/NX on day 3 and tapering to 2 mg/ 0.5 mg BUP/NX by days 12 to 13. Patients randomized to the clonidine arm will receive oral clonidine (0.05 to 0.1 mg depending upon weight) every 4 to 6 hours for 24 hours not to exceed 0.6 mg total on day 1. On day 2, a clonidine transdermal patch will be applied (0.1 mg/day/7-day patch with number of patches adjusted by weight). Oral clonidine will continue to be given on the second day of detoxification and increased to 0.2 mg every 6 hours or 0.1 mg every 3 hours not to exceed 0.8 mg over 24 hours. Patches will be worn all 13 days of detoxification. The dose of clonidine will be adjusted according to the proposed detoxification schedule, patient's weight, tolerance, and systolic blood pressure. Patients will receive counseling according to procedures in existence at each CTP throughout the study. Self-help detoxification handbooks will be distributed to all study participants.
- Being tested
- Buprenorphine/naloxone
- Keywords
- opiate addiction, morphine addiction
- Medical subject headings
- Heroin Dependence, Morphine Dependence, Substance Withdrawal Syndrome, 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.
Drug use
Degree of drug craving
Adverse events
Drug craving
Decreased frequency of HIV related behavior
Adverse effect measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2002 (estimated)
- Study startFeb 2001
- Primary completionAug 2002
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heroin DependenceStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 3
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 163 participants
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Investigators
- Walter Ling, M.D., Principal investigator, Los Angeles Treatment Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00032955
- Sponsor's protocol ID
- NIDA-CTN-0001-1
- Status last verified
- Apr 2010
- First submitted
- 5 Apr 2002
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
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
- Buprenorphine/Naloxone Versus Clonidine for Inpatient Opiate Detoxification
- ClinicalTrials.gov ID
- NCT00032955
- Acronym / sponsor ID
- NIDA-CTN-0001-1
- Keywords
- opiate addiction, morphine addiction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Feb 2001
- Primary completion
- Aug 2002 (actual)
- Study completion
- Aug 2002 (actual)
- First posted
- 8 Apr 2002 (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 buprenorphine/naloxone versus clonidine for inpatient opiate detoxification.
Detailed description
Patients randomized to the BUP/NX arm will receive daily doses for 13 days with sublingual administration of 2 mg buprenorphine/0.5 mg naloxone tablet(s) and/or an 8 mg buprenorphine/2.0 mg naloxone tablet(s). The starting dose on day 1 is 4 mg/1 mg BUP/NX with an additional 4 mg/1 mg, if needed, escalating in a step-wise manner to 16 mg/4 mg BUP/NX on day 3 and tapering to 2 mg/ 0.5 mg BUP/NX by days 12 to 13. Patients randomized to the clonidine arm will receive oral clonidine (0.05 to 0.1 mg depending upon weight) every 4 to 6 hours for 24 hours not to exceed 0.6 mg total on day 1. On day 2, a clonidine transdermal patch will be applied (0.1 mg/day/7-day patch with number of patches adjusted by weight). Oral clonidine will continue to be given on the second day of detoxification and increased to 0.2 mg every 6 hours or 0.1 mg every 3 hours not to exceed 0.8 mg over 24 hours. Patches will be worn all 13 days of detoxification. The dose of clonidine will be adjusted according to the proposed detoxification schedule, patient's weight, tolerance, and systolic blood pressure. Patients will receive counseling according to procedures in existence at each CTP throughout the study. Self-help detoxification handbooks will be distributed to all study participants.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Treatment-seeking males and non-pregnant and non-lactating females, 15 years and older, who fulfill DSM-IV criteria for opiate dependence, report experiencing symptoms of opiate withdrawal, are currently physically dependent on opioids, and are need of medical assistance for opioid withdrawal.
- Systolic blood pressure > or = 100mm Hg, and pulse > or = 56 bpm.
- Good general health or, in case of a medical/psychiatric condition needing ongoing treatment, under the care of a physician willing to continue patient's medical management and cooperate with the study physicians.
- Agreeable to and capable of signing the informed consent approved by an institutional review board and, if under the age of 18 (excluding emancipated minors), assent and concurrent consent from a parent or legal guardian.
- Use of one of the following acceptable methods of birth control by female patients of childbearing potential:
Key exclusion criteria (11 listed)
- Medical condition that would make participation, in the opinion of the study physician, medically hazardous (e.g., acute hepatitis, unstable cardiovascular, liver or renal disease);
- Clinically significant abnormalities in ECG.
- Known allergy or sensitivity to buprenorphine, naloxone, or clonidine.
- Receiving beta-blockers, calcium channel blockers, tricyclics, digitalis and other medications which may interact adversely with clonidine.
- Acute severe psychiatric condition in need of immediate treatment, or imminent suicide risk.
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
Drug use
Degree of drug craving
Adverse events
Drug craving
Decreased frequency of HIV related behavior
Adverse effect measures
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.
- Data ElementsLink provided by the sponsor.
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.
Walter Ling, M.D. principal investigator
Los Angeles Treatment Research Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Buprenorphine/naloxone in people with Heroin Dependence and Morphine Dependence, run by University of California, Los Angeles at 6 sites 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 11 inclusion and 11 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 6 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Drug use. The study lists 6 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.