Buprenorphine/Naloxone Versus Clonidine for Outpatient Opiate Detoxification - 1

Completed · Phase 3

Conditions studied: Heroin Dependence, Morphine Dependence, Substance Withdrawal Syndrome

In brief

The purpose of this study is to assess buprenorphine/naloxone versus clonidine for outpatient opiate detoxification.

Key facts

Study ID

NCT00032968

Run by

University of California, Los Angeles

People needed

341

Starts

2001-01-01

Expected to finish

2002-08-01

Last updated by the study team

2017-01-12

Who can join

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

You may qualify if…

• 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 in need of medical assistance for opioid withdrawal.
• Systolic blood pressure 100 mm Hg, and pulse 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
• barrier (diaphragm or cervical cap) with spermicide or condom
• intrauterine progesterone contraceptive system
• levonorgestrel implant
• medroxyprogesterone acetate contraceptive injection
• complete abstinence from sexual intercourse

You may not qualify if…

• 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.
• 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.

Where it is running

• Haight-Ashbury Free Clinic — Berkeley, California, United States
• Aegis Medical Systems, Inc. — Oxnard, California, United States
• Midtown Community Mental Health Center — Indianapolis, Indiana, United States
• UMDNJ - Robert Wood Johnson Medical School — Piscataway, New Jersey, United States
• Addiction Research and Treatment Corp — Brooklyn, New York, United States
• Bellevue — New York, New York, United States
• Kaiser Permanente Northwest, Division of Addiction — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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