Optimizing Outcomes Using Suboxone for Opiate Dependence

Completed · Not applicable

Conditions studied: Opioid Dependency

In brief

Building on a platform of pharmacological treatment with Suboxone (buprenorphine and naloxone), participants are randomly assigned to one of four psychosocial treatment conditions.

Key facts

Study ID

NCT00591617

Run by

University of California, Los Angeles

People needed

202

Starts

2006-09-01

Expected to finish

2012-12-01

Last updated by the study team

2013-01-29

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 Females who become pregnant during the course of the study will be withdrawn from the study and referred to an appropriate treatment venue; i.e. narcotic treatment program or specialty addiction clinic.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. -

Where it is running

• UCLA Integrated Substance Abuse Programs Outpatient Clinical Research Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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