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

Condition	Treatment or Intervention	Phase
Heroin Dependence Morphine Dependence Substance Withdrawal Syndrome	Drug: Buprenorphine/naloxone	Phase III

Further Study Details: 

Expected Total Enrollment:  341

Patients randomized to the BUP/NX arm will receive daily doses for 13 days with sublingual administration of 2 mg buprenorphine/0.5 mg naloxone tablet(s) and/or an 8 mg buprenorphine/2.0 mg naloxone tablet(s). The starting dose on day 1 is 4 mg/1 mg BUP/NX with an additional 4 mg/1 mg, if needed, escalating in a step-wise manner to 16 mg/4 mg BUP/NX on day 3 and tapering to 2 mg/ 0.5 mg BUP/NX by days 12 to 13. Patients randomized to the clonidine arm will receive oral clonidine (0.05 to 0.1 mg depending upon weight) every 4 to 6 hours for 24 hours not to exceed 0.6 mg total on day 1. On day 2, a clonidine transdermal patch will be applied (0.1 mg/day/7-day patch with number of patches adjusted by weight). Oral clonidine will continue to be given on the second day of detoxification and increased to 0.2 mg every 6 hours or 0.1 mg every 3 hours not to exceed 0.8 mg over 24 hours. Patches will be worn all 13 days of detoxification. The dose of clonidine will be adjusted according to the proposed detoxification schedule, patient's weight, tolerance, and systolic blood pressure. Patients will receive counseling according to procedures in existence at each CTP throughout the study. Self-help detoxification handbooks will be distributed to all study participants.

Ages Eligible for Study:  15 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

1. 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.

2. Systolic blood pressure 100 mm Hg, and pulse 56 bpm.

3. 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.

4. 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.

5. Use of one of the following acceptable methods of birth control by female patients of childbearing potential:

a. oral contraceptives

b. barrier (diaphragm or cervical cap) with spermicide or condom

c. intrauterine progesterone contraceptive system

d. levonorgestrel implant

e. medroxyprogesterone acetate contraceptive injection

f. complete abstinence from sexual intercourse

Exclusion Criteria:

1. 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);

2. Clinically significant abnormalities in ECG.

3. Known allergy or sensitivity to buprenorphine, naloxone, or clonidine.

4. Receiving beta-blockers, calcium channel blockers, tricyclics, digitalis and other medications which may interact adversely with clonidine.

5. Acute severe psychiatric condition in need of immediate treatment, or imminent suicide risk.

6. Dependence on alcohol, benzodiazepines or other depressants, or stimulants, and requiring immediate medical attention.

7. Participation in an investigational drug study, including buprenorphine, within the past 30 days.

8. Methadone or LAAM maintenance or detoxification within 30 days of enrollment.

9. Pending legal action that could prohibit or interfere with participation.

10. Unable to remain in area for duration of active phase of treatment.

11. Females that are pregnant, lactating, or planning to become pregnant.

California
      Aegis Medical Systems, Inc., Oxnard,  California,  93033,  United States
      Haight-Ashbury Free Clinic, Berkeley,  California,  94704,  United States
Indiana
      Midtown Community Mental Health Center, Indianapolis,  Indiana,  46202,  United States
New Jersey
      UMDNJ - Robert Wood Johnson Medical School, Piscataway,  New Jersey,  08854,  United States
New York
      Addiction Research and Treatment Corp, Brooklyn,  New York,  11201,  United States
      Bellevue, New York,  New York,  10016,  United States
Oregon
      Kaiser Permanente Northwest, Division of Addiction, Portland,  Oregon,  97227,  United States

Study chairs or principal investigators

Walter Ling, M.D.,  Principal Investigator,  Los Angeles Treatment Research Center   

Study ID Numbers:  NIDA-CTN-0002-1
Record last reviewed:  March 2004
Last Updated:  March 17, 2005
Record first received:  April 5, 2002
ClinicalTrials.gov Identifier:  NCT00032968
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08