Opioid DependencyOpBupNCT00591617
Optimizing Outcomes Using Suboxone for Opiate Dependence
A study testing Psychosocial treatment plus Suboxone pharmacotherapy in people with Opioid Dependency, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Building on a platform of pharmacological treatment with Suboxone (buprenorphine and naloxone), participants are randomly assigned to one of four psychosocial treatment conditions. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Opioid Dependency
- What is being tested?
- Psychosocial treatment plus Suboxone pharmacotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Dec 2012
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants must:
- Be 15 years of age or older.
- Meet DSM-IV-TR criteria for opioid dependence.
- Be interested in receiving buprenorphine treatment for their opioid dependence.
- Be in good general health or, in case of a medical/psychiatric condition needing ongoing treatment, be under the care of a physician who provides documented willingness to continue participant's medical management and coordinate care with the study physicians. *
- Be agreeable to and capable of signing an informed consent.
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- Have means of reliable transportation over the study period.
- If female and of child bearing potential, agree to use of one of the following methods of birth control or be surgically sterile:
- oral contraceptives
- patch
- barrier (diaphragm or condom)
- intrauterine contraceptive system
- levonorgestrel implant
- medroxyprogesterone acetate contraceptive injection
- complete abstinence from sexual intercourse
- hormonal vaginal contraceptive ring
- Be agreeable to and capable of complying with study procedures.
Who cannot join
- Participants must not:
- Have a known sensitivity to buprenorphine or naloxone.
- Be dependent on alcohol, benzodiazepines or other drugs of abuse that require immediate medical attention.
- Have a medical condition that would, in the opinion of the study physician, make participation medically hazardous (e.g., acute hepatitis, unstable cardiovascular, liver or renal disease).
- Have a current pattern of benzodiazepine use, as assessed by the study physician, which would preclude safe participation in the study.
- Be actively involved in another clinical trial.
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- Be acutely psychotic, severely depressed, and in need of inpatient treatment, or is an immediate suicide risk.
- Be a nursing or pregnant female. Females who become pregnant during the course of the study will be withdrawn from the study and referred to an appropriate treatment venue; i.e. narcotic treatment program or specialty addiction clinic.
- Be a female of childbearing potential who does not agree to use a medically acceptable method of birth control, e.g. oral contraceptives, barrier (diaphragm or condom) with or without spermicide, levonorgestrel implant, intra-uterine progesterone contraceptives system, medroxyprogesterone acetate contraceptive injection, or complete abstinence.
- Have any pending legal action that could prohibit continued participation for the one-year period of study participation (such as that which could possibly result in incarceration).
- Be expecting to leave the clinic's geographic area prior to study completion (within one year).
- Have been previously randomized to a treatment condition in this study. -
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Integrated Substance Abuse Programs Outpatient Clinical Research Center
Los Angeles, California, 90025
About this study
Building on a platform of pharmacological treatment with Suboxone (buprenorphine and naloxone), participants are randomly assigned to one of four psychosocial treatment conditions.
Read the detailed description
The approval of buprenorphine (combined with naloxone as Suboxone®) by the FDA enables physicians in the United States to provide pharmacotherapy treatment to opioid-dependent patients in private medical settings. Buprenorphine's wide acceptance and implementation by physicians has been slower than expected, however, and this may be due in part to the nature and necessity of providing comprehensive treatment for opioid-dependent patients. Lessons learned from methadone maintenance make it clear that simply providing opioid substitution does not address the behavioral components of dependence. While there is no lack of behavioral treatment facilities for substance abuse in the United States, what is lacking is an integrative approach to the treatment of opioid dependence using pharmacotherapy in conjunction with proven behavioral treatment strategies. Following a two-week stabilization and baseline period, this project will randomize 240 participants into 4 behavioral treatment groups featuring cognitive behavioral therapy and contingency management therapy. A universal, manual-guided psychosocial standard of care for buprenorphine pharmacological treatment allows for ethical inclusion of a "no-CBT or CM therapy" condition and closely resembles the current standard of psychosocial care delivered with opioid treatment using Suboxone®. Behavioral therapies will be delivered for 16 weeks (to study week 18) in conjunction with continued care with Suboxone®. An additional 16 weeks of treatment using Suboxone® (to study week 34) will ensue during which no CBT or CM therapies are provided. All participants enter a buprenorphine taper and return at study week 52 for long-term follow-up evaluations. Outcomes for the trial include illicit drug use (urine drug samples collected three times per week during the first 18 weeks), drug craving, retention (days in the protocol), psychiatric status (depression, mood), HIV risk behaviors, and treatment feasibility ratings. Results will be used to recommend strategies to optimize buprenorphine treatment outcomes and promote integration of pharmacotherapy and psychosocial/behavioral treatment strategies for physicians and for behavioral treatment facilities treating opioid-dependent patients.
- Conditions
- Opioid Dependency
- Being tested
- Psychosocial treatment plus Suboxone pharmacotherapy
- Keywords
- Opioids, drug dependence, drug abuse, treatment
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial treatment plus Suboxone pharmacotherapyOther
Participants randomly assigned to one of four psychosocial treatment conditions building on pharmacotherapy with Suboxone (buprenorphine + naloxone)
| Study group | Role | What they receive |
|---|---|---|
| 1: MM | Active comparator | Medical Management: group receives medical management from study physician and Suboxone pharmacotherapy Receives: Other: Psychosocial treatment plus Suboxone pharmacotherapy |
| 2: CBT | Active comparator | Cognitive Behavioral Therapy (CBT) group receives CBT, medical management and Suboxone pharmacotherapy Receives: Other: Psychosocial treatment plus Suboxone pharmacotherapy |
| 3: CM | Active comparator | Contingency Management (CM) group receives CM, medical management, and Suboxone pharmacotherapy Receives: Other: Psychosocial treatment plus Suboxone pharmacotherapy |
| 4: CBT + CM | Active comparator | Cognitive Behavioral Therapy (CBT) and Contingency Management (CM) group receives CBT, CM, medical management, and Suboxone pharmacotherapy Receives: Other: Psychosocial treatment plus Suboxone pharmacotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison the effectiveness of four psychosocial treatment conditions as measured by self-reported abstinence from opioids verified by urine toxicology tests
Measured: Week 18 - At end of first phase
Secondary outcomes (3)
Comparison across treatment conditions for reducing the severity of opioid-related problems
Measured: at end of Phase 1 (wk 18), phase 2 (wk 34) and two follow-up timepoints (wks. 40 and 52)
Comparison across treatment conditions for reducing the proportion of use-days of other substances of abuse (alcohol, marijuana, amphetamines, methamphetamines, benzodiazepines and barbiturates) as determined by self-report and urine test results.
Measured: At end of Phase 1 (wk. 18), Phase 2 (wk. 34), and at two follow-ups (wks. 40 and 52)
Comparison across treatment conditions in reducing psychiatric and mood disturbance as measured with the BDI and SF-36.
Measured: At end of Phase 1 (wk. 18), Phase 2 (wk. 34), and at two follow-ups (wks. 40 and 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startSep 2006
- Primary completionJan 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid DependencyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walter Ling, University of California, Los Angeles
- Investigators
- Walter Ling, M.D., Principal investigator, UCLA Integrated Substance Abuse ProgramsMaureen Hillhouse, Ph.D., Study director, UCLA Integrated Substance Abuse Programs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591617
- Sponsor's protocol ID
- 5R01DA020210
- Acronym
- OpBup
- Status last verified
- Jan 2013
- First submitted
- 28 Dec 2007
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McHugh RK, Bailey AJ, McConaghy BA, Weiss RD, Fiellin DA, Hillhouse M, Moore BA, Fitzmaurice GM. Behavioral Therapy as an Adjunct to Buprenorphine Treatment for Opioid Use Disorder: A Secondary Analysis of 4 Randomized Clinical Trials. JAMA Netw Open. 2025 Aug 1;8(8):e2528529. doi: 10.1001/jamanetworkopen.2025.28529.
PubMed 40833692Nielsen S, Hillhouse M, Mooney L, Fahey J, Ling W. Comparing buprenorphine induction experience with heroin and prescription opioid users. J Subst Abuse Treat. 2012 Oct;43(3):285-90. doi: 10.1016/j.jsat.2011.12.009. Epub 2012 Feb 1.
PubMed 22301084
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Outcomes Using Suboxone for Opiate Dependence
- ClinicalTrials.gov ID
- NCT00591617
- Acronym / sponsor ID
- OpBup / 5R01DA020210
- Conditions
- Opioid Dependency
- Keywords
- Opioids, drug dependence, drug abuse, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jan 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Jan 2008 (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.
Building on a platform of pharmacological treatment with Suboxone (buprenorphine and naloxone), participants are randomly assigned to one of four psychosocial treatment conditions.
Detailed description
The approval of buprenorphine (combined with naloxone as Suboxone®) by the FDA enables physicians in the United States to provide pharmacotherapy treatment to opioid-dependent patients in private medical settings. Buprenorphine's wide acceptance and implementation by physicians has been slower than expected, however, and this may be due in part to the nature and necessity of providing comprehensive treatment for opioid-dependent patients. Lessons learned from methadone maintenance make it clear that simply providing opioid substitution does not address the behavioral components of dependence. While there is no lack of behavioral treatment facilities for substance abuse in the United States, what is lacking is an integrative approach to the treatment of opioid dependence using pharmacotherapy in conjunction with proven behavioral treatment strategies. Following a two-week stabilization and baseline period, this project will randomize 240 participants into 4 behavioral treatment groups featuring cognitive behavioral therapy and contingency management therapy. A universal, manual-guided psychosocial standard of care for buprenorphine pharmacological treatment allows for ethical inclusion of a "no-CBT or CM therapy" condition and closely resembles the current standard of psychosocial care delivered with opioid treatment using Suboxone®. Behavioral therapies will be delivered for 16 weeks (to study week 18) in conjunction with continued care with Suboxone®. An additional 16 weeks of treatment using Suboxone® (to study week 34) will ensue during which no CBT or CM therapies are provided. All participants enter a buprenorphine taper and return at study week 52 for long-term follow-up evaluations. Outcomes for the trial include illicit drug use (urine drug samples collected three times per week during the first 18 weeks), drug craving, retention (days in the protocol), psychiatric status (depression, mood), HIV risk behaviors, and treatment feasibility ratings. Results will be used to recommend strategies to optimize buprenorphine treatment outcomes and promote integration of pharmacotherapy and psychosocial/behavioral treatment strategies for physicians and for behavioral treatment facilities treating opioid-dependent patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1: MM | Active comparator | Other: Psychosocial treatment plus Suboxone pharmacotherapyMedical Management: group receives medical management from study physician and Suboxone pharmacotherapy |
| 2: CBT | Active comparator | Other: Psychosocial treatment plus Suboxone pharmacotherapyCognitive Behavioral Therapy (CBT) group receives CBT, medical management and Suboxone pharmacotherapy |
| 3: CM | Active comparator | Other: Psychosocial treatment plus Suboxone pharmacotherapyContingency Management (CM) group receives CM, medical management, and Suboxone pharmacotherapy |
| 4: CBT + CM | Active comparator | Other: Psychosocial treatment plus Suboxone pharmacotherapyCognitive Behavioral Therapy (CBT) and Contingency Management (CM) group receives CBT, CM, medical management, and Suboxone pharmacotherapy |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Be 15 years of age or older.
- Meet DSM-IV-TR criteria for opioid dependence.
- Be interested in receiving buprenorphine treatment for their opioid dependence.
- Be in good general health or, in case of a medical/psychiatric condition needing ongoing treatment, be under the care of a physician who provides documented willingness to continue participant's medical management and coordinate care with the study physicians. *
- Be agreeable to and capable of signing an informed consent.
Key exclusion criteria (12 listed)
- Have a known sensitivity to buprenorphine or naloxone.
- Be dependent on alcohol, benzodiazepines or other drugs of abuse that require immediate medical attention.
- Have a medical condition that would, in the opinion of the study physician, make participation medically hazardous (e.g., acute hepatitis, unstable cardiovascular, liver or renal disease).
- Have a current pattern of benzodiazepine use, as assessed by the study physician, which would preclude safe participation in the study.
- Be actively involved in another clinical trial.
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 |
|---|---|---|
| Psychosocial treatment plus Suboxone pharmacotherapyParticipants randomly assigned to one of four psychosocial treatment conditions building on pharmacotherapy with Suboxone (buprenorphine + naloxone) | Other | 1: MM, 2: CBT, 3: CM, 4: CBT + CM |
Primary outcome
Comparison the effectiveness of four psychosocial treatment conditions as measured by self-reported abstinence from opioids verified by urine toxicology tests
Time frame: Week 18 - At end of first phase
3 secondary outcomes
Comparison across treatment conditions for reducing the severity of opioid-related problems
Time frame: at end of Phase 1 (wk 18), phase 2 (wk 34) and two follow-up timepoints (wks. 40 and 52)
Comparison across treatment conditions for reducing the proportion of use-days of other substances of abuse (alcohol, marijuana, amphetamines, methamphetamines, benzodiazepines and barbiturates) as determined by self-report and urine test results.
Time frame: At end of Phase 1 (wk. 18), Phase 2 (wk. 34), and at two follow-ups (wks. 40 and 52)
Comparison across treatment conditions in reducing psychiatric and mood disturbance as measured with the BDI and SF-36.
Time frame: At end of Phase 1 (wk. 18), Phase 2 (wk. 34), and at two follow-ups (wks. 40 and 52)
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 29 Jan 2013.
- Derived from this study: PubMed 40833692McHugh RK, Bailey AJ, McConaghy BA, Weiss RD, Fiellin DA, Hillhouse M, Moore BA, Fitzmaurice GM. Behavioral Therapy as an Adjunct to Buprenorphine Treatment for Opioid Use Disorder: A Secondary Analysis of 4 Randomized Clinical Trials. JAMA Netw Open. 2025 Aug 1;8(8):e2528529. doi: 10.1001/jamanetworkopen.2025.28529.
- Derived from this study: PubMed 22301084Nielsen S, Hillhouse M, Mooney L, Fahey J, Ling W. Comparing buprenorphine induction experience with heroin and prescription opioid users. J Subst Abuse Treat. 2012 Oct;43(3):285-90. doi: 10.1016/j.jsat.2011.12.009. Epub 2012 Feb 1.
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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
UCLA Integrated Substance Abuse Programs
Maureen Hillhouse, Ph.D. study director
UCLA Integrated Substance Abuse Programs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial treatment plus Suboxone pharmacotherapy in people with Opioid Dependency, run by University of California, Los Angeles 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 17 inclusion and 12 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 29 Jan 2013. 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?
Comparison the effectiveness of four psychosocial treatment conditions as measured by self-reported abstinence from opioids verified by urine toxicology tests (time frame: Week 18 - At end of first phase). 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 NCT00591617, which also lists 2 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 29 Jan 2013.