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Home > "B" Clinical Trials Conditions > Buprenorphine/Naloxone versus Clonidine For Out-patient Opiate Detoxification - 1  Buprenorphine/Naloxone versus Clonidine For Out-patient Opiate Detoxification - 1
Buprenorphine/Naloxone versus Clonidine For Out-patient Opiate Detoxification - 1
For Condition: Substance Withdrawal Syndrome,Heroin Dependence,Morphine Dependence
Status: No longer recruiting
Sponsor(s): National Institute on Drug Abuse (NIDA) ,
Synopsis: Buprenorphine/Naloxone versus Clonidine For Out-patient Opiate Detoxification
Details: 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:
Study Type: Interventional, Treatment, Randomized, Open Label, Uncontrolled
Minimum Age/Maximum Age: 15 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 341
Location and Contact Information:
Overall Study Official:
WalterLing, Principal Investigator, Los Angeles Treatment Research Center
Bellevue
New York City, New York, 10016
United States
Midtown Community Mental Health Center
Indianapolis, Indiana, 46202
United States
Haight-Ashbury Free Clinic
Berkeley, California, 94704
United States
Kaiser Permanente Northwest, Division of Addiction
Portland, Oregon, 97227
United States
Aegis Medical Systems, Inc.
Oxnard, California, 93033
United States
UMDNJ - Robert Wood Johnson Medical School
Piscataway, New Jersey, 08854
United States
Addiction Research and Treatment Corp
Brooklyn, New York, 11201
United States
Additional Information:
Study ID Numbers: NIDA-CTN-0002-1;
Study Start Date: January 2001
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032968
Other Heroin Dependence Studies:
1. Buprenorphine/Naloxone versus Clonidine For Out-patient Opiate Detoxification - 1
2. Buprenorphine/Naloxone versus Clonidine for Inpatient Opiate Detoxification - 1
Related Studies:
Other Heroin Dependence Clinical Trials
Other Oregon Clinical Trials
Other Portland Clinical Trials
Buprenorphine/Naloxone versus Clonidine For Out-patient Opiate Detoxification - 1
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