Opioid-Related DisordersPhase 3NCT00078117
Suboxone: (Buprenorphine/Naloxone) Comparison of Two Taper Schedules - 1
A Phase 3 study testing Buprenorphine in people with Opioid-Related Disorders, run by University of California, Los Angeles at 11 sites in United States.
Trial summary
The purpose of this protocol is to to compare the clinical utility of two dosage tapering regimens in Buprenorphine/Naloxone stabilized subjects for opiate detoxification. Read more about this study
- Who is it for?
- Ages 15 to 99 years
- Conditions the study is for
- Opioid-Related Disorders
- What is being tested?
- Buprenorphine
- How many people
- 516 participants
- Where
- 11 sitesUnited States
- Study dates
- Jun 2003to May 2005
- 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 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Females are not pregnant or lactating
- Subjects meet DSM-IV criteria for opiate dependence, are medically and psychiatrically stable, and do not have a current history of benzodiazepine dependence abuse, dependence, or treatment
Who cannot join
None listed.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Addiction Research & Treatment Services (ARTS)
Denver, Colorado, 80204
Denver Health & Hospitals Authority
Denver, Colorado, 80204
Providence Behavioral Health Services
Everett, Washington, 98201
LI Jewish Health System
Glen Oaks, New York, 11004
Hartford Dispensary
Hartford, Connecticut, 06120
New York VA Medical Center
New York, New York, 10010
Norfolk CSB
Norfolk, Virginia, 23505
CODA
Portland, Oregon, 97214
South Light-Wakeview Clinic
Raleigh, North Carolina, 27610
Connecticut Counseling Centers
Waterbury, Connecticut, 06705
Coastal Horizons Center, Inc.
Wilmington, North Carolina, 28412
About this study
Official title: Suboxone: (Buprenorphine/Naloxone) Comparison of Two Taper Schedules
The purpose of this protocol is to to compare the clinical utility of two dosage tapering regimens in Buprenorphine/Naloxone stabilized subjects for opiate detoxification.
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Opiate abstinence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2004 (estimated)
- Study startJun 2003
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Opioid-Related DisordersStudies 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
- Enrolment
- 516 participants
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Investigators
- Walter Ling, M.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00078117
- Sponsor's protocol ID
- NIDA-CTN-0003-1
- Status last verified
- Apr 2010
- First submitted
- 19 Feb 2004
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nielsen S, Hillhouse M, Thomas C, Hasson A, Ling W. A comparison of buprenorphine taper outcomes between prescription opioid and heroin users. J Addict Med. 2013 Jan-Feb;7(1):33-8. doi: 10.1097/ADM.0b013e318277e92e.
PubMed 23222095Hillhouse M, Canamar CP, Ling W. Predictors of outcome after short-term stabilization with buprenorphine. J Subst Abuse Treat. 2013 Mar;44(3):336-42. doi: 10.1016/j.jsat.2012.08.016. Epub 2012 Sep 26.
PubMed 23021099Back SE, Payne RL, Wahlquist AH, Carter RE, Stroud Z, Haynes L, Hillhouse M, Brady KT, Ling W. Comparative profiles of men and women with opioid dependence: results from a national multisite effectiveness trial. Am J Drug Alcohol Abuse. 2011 Sep;37(5):313-23. doi: 10.3109/00952990.2011.596982.
PubMed 21854273Ling W, Hillhouse M, Domier C, Doraimani G, Hunter J, Thomas C, Jenkins J, Hasson A, Annon J, Saxon A, Selzer J, Boverman J, Bilangi R. Buprenorphine tapering schedule and illicit opioid use. Addiction. 2009 Feb;104(2):256-65. doi: 10.1111/j.1360-0443.2008.02455.x.
PubMed 19149822
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
- Suboxone: (Buprenorphine/Naloxone) Comparison of Two Taper Schedules
- ClinicalTrials.gov ID
- NCT00078117
- Acronym / sponsor ID
- NIDA-CTN-0003-1
- Conditions
- Opioid-Related Disorders
- Keywords
- opiate dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 20 Feb 2004 (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 protocol is to to compare the clinical utility of two dosage tapering regimens in Buprenorphine/Naloxone stabilized subjects for opiate detoxification.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 15 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Females are not pregnant or lactating
- Subjects meet DSM-IV criteria for opiate dependence, are medically and psychiatrically stable, and do not have a current history of benzodiazepine dependence abuse, dependence, or treatment
Key exclusion criteria (0 listed)
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 | Drug | – |
Primary outcome
Opiate abstinence
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.
- Derived from this study: PubMed 23222095Nielsen S, Hillhouse M, Thomas C, Hasson A, Ling W. A comparison of buprenorphine taper outcomes between prescription opioid and heroin users. J Addict Med. 2013 Jan-Feb;7(1):33-8. doi: 10.1097/ADM.0b013e318277e92e.
- Derived from this study: PubMed 23021099Hillhouse M, Canamar CP, Ling W. Predictors of outcome after short-term stabilization with buprenorphine. J Subst Abuse Treat. 2013 Mar;44(3):336-42. doi: 10.1016/j.jsat.2012.08.016. Epub 2012 Sep 26.
- Derived from this study: PubMed 21854273Back SE, Payne RL, Wahlquist AH, Carter RE, Stroud Z, Haynes L, Hillhouse M, Brady KT, Ling W. Comparative profiles of men and women with opioid dependence: results from a national multisite effectiveness trial. Am J Drug Alcohol Abuse. 2011 Sep;37(5):313-23. doi: 10.3109/00952990.2011.596982.
- Derived from this study: PubMed 19149822Ling W, Hillhouse M, Domier C, Doraimani G, Hunter J, Thomas C, Jenkins J, Hasson A, Annon J, Saxon A, Selzer J, Boverman J, Bilangi R. Buprenorphine tapering schedule and illicit opioid use. Addiction. 2009 Feb;104(2):256-65. doi: 10.1111/j.1360-0443.2008.02455.x.
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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.
Walter Ling, M.D. principal investigator
University of California, Los Angeles
11 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 in people with Opioid-Related Disorders, run by University of California, Los Angeles at 11 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 2 inclusion and 0 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 11 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?
Opiate abstinence. 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 NCT00078117, which also lists 4 linked publications.
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.