Clinical trial NCT00032968: Buprenorphine/Naloxone Versus Clonidine for Outpatient Opiate Detoxification - 1
Official title: Buprenorphine/Naloxone Versus Clonidine For Out-patient Opiate Detoxification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heroin Dependence
Morphine Dependence
Substance Withdrawal Syndrome
Keywords: opiate dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2002-04-08
Enrollment: 341
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility 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:

   1. oral contraceptives
   2. barrier (diaphragm or cervical cap) with spermicide or condom
   3. intrauterine progesterone contraceptive system
   4. levonorgestrel implant
   5. medroxyprogesterone acetate contraceptive injection
   6. 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.

Primary outcomes:
measure: Drug use
measure: Degree of drug craving
measure: Opiate craving
measure: Adverse events
measure: Drug craving
measure: Decreased frequency of HIV related behavior
measure: Adverse effect measures
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Haight-Ashbury Free Clinic
state: California
city: Oxnard
country: United States
facility: Aegis Medical Systems, Inc.
state: California
city: Indianapolis
country: United States
facility: Midtown Community Mental Health Center
state: Indiana
city: Piscataway
country: United States
facility: UMDNJ - Robert Wood Johnson Medical School
state: New Jersey
city: Brooklyn
country: United States
facility: Addiction Research and Treatment Corp
state: New York
city: New York
country: United States
facility: Bellevue
state: New York
city: Portland
country: United States
facility: Kaiser Permanente Northwest, Division of Addiction
state: Oregon
Study officials:
affiliation: Los Angeles Treatment Research Center
name: Walter Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
References: