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Optimizing Outcomes Using Suboxone for Opiate Dependence (OpBup)

Primary Purpose

Opioid Dependency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychosocial treatment plus Suboxone pharmacotherapy
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Dependency focused on measuring Opioids, drug dependence, drug abuse, treatment

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants must:

  1. Be 15 years of age or older.
  2. Meet DSM-IV-TR criteria for opioid dependence.
  3. Be interested in receiving buprenorphine treatment for their opioid dependence.
  4. 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. *
  5. Be agreeable to and capable of signing an informed consent.
  6. Have means of reliable transportation over the study period.

  7. If female and of child bearing potential, agree to use of one of the following methods of birth control or be surgically sterile:

    1. oral contraceptives
    2. patch
    3. barrier (diaphragm or condom)
    4. intrauterine contraceptive system
    5. levonorgestrel implant
    6. medroxyprogesterone acetate contraceptive injection
    7. complete abstinence from sexual intercourse
    8. hormonal vaginal contraceptive ring
  8. Be agreeable to and capable of complying with study procedures.

Exclusion Criteria:

Participants must not:

  1. Have a known sensitivity to buprenorphine or naloxone.
  2. Be dependent on alcohol, benzodiazepines or other drugs of abuse that require immediate medical attention.
  3. 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).
  4. Have a current pattern of benzodiazepine use, as assessed by the study physician, which would preclude safe participation in the study.
  5. Be actively involved in another clinical trial.
  6. Be acutely psychotic, severely depressed, and in need of inpatient treatment, or is an immediate suicide risk.
  7. 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.
  8. 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.
  9. 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).
  10. Be expecting to leave the clinic's geographic area prior to study completion (within one year).
  11. Have been previously randomized to a treatment condition in this study. -

Sites / Locations

  • UCLA Integrated Substance Abuse Programs Outpatient Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1: MM

2: CBT

3: CM

4: CBT + CM

Arm Description

Medical Management: group receives medical management from study physician and Suboxone pharmacotherapy

Cognitive Behavioral Therapy (CBT) group receives CBT, medical management and Suboxone pharmacotherapy

Contingency Management (CM) group receives CM, medical management, and Suboxone pharmacotherapy

Cognitive Behavioral Therapy (CBT) and Contingency Management (CM) group receives CBT, CM, medical management, and Suboxone pharmacotherapy

Outcomes

Primary Outcome Measures

Comparison the effectiveness of four psychosocial treatment conditions as measured by self-reported abstinence from opioids verified by urine toxicology tests

Secondary Outcome Measures

Comparison across treatment conditions for reducing the severity of opioid-related problems
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.
Comparison across treatment conditions in reducing psychiatric and mood disturbance as measured with the BDI and SF-36.

Full Information

First Posted
December 28, 2007
Last Updated
January 28, 2013
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT00591617
Brief Title
Optimizing Outcomes Using Suboxone for Opiate Dependence
Acronym
OpBup
Official Title
Optimizing Outcomes Using Suboxone for Opiate Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependency
Keywords
Opioids, drug dependence, drug abuse, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: MM
Arm Type
Active Comparator
Arm Description
Medical Management: group receives medical management from study physician and Suboxone pharmacotherapy
Arm Title
2: CBT
Arm Type
Active Comparator
Arm Description
Cognitive Behavioral Therapy (CBT) group receives CBT, medical management and Suboxone pharmacotherapy
Arm Title
3: CM
Arm Type
Active Comparator
Arm Description
Contingency Management (CM) group receives CM, medical management, and Suboxone pharmacotherapy
Arm Title
4: CBT + CM
Arm Type
Active Comparator
Arm Description
Cognitive Behavioral Therapy (CBT) and Contingency Management (CM) group receives CBT, CM, medical management, and Suboxone pharmacotherapy
Intervention Type
Other
Intervention Name(s)
Psychosocial treatment plus Suboxone pharmacotherapy
Intervention Description
Participants randomly assigned to one of four psychosocial treatment conditions building on pharmacotherapy with Suboxone (buprenorphine + naloxone)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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. 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Ling, M.D.
Organizational Affiliation
UCLA Integrated Substance Abuse Programs
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maureen Hillhouse, Ph.D.
Organizational Affiliation
UCLA Integrated Substance Abuse Programs
Official's Role
Study Director
Facility Information:
Facility Name
UCLA Integrated Substance Abuse Programs Outpatient Clinical Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22301084
Citation
Nielsen 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.
Results Reference
derived

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Optimizing Outcomes Using Suboxone for Opiate Dependence

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