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Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) - 2



Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) - 2

For Condition: Heroin Dependence,Opioid-Related Disorders
Status: Completed
Sponsor(s): National Institute on Drug Abuse (NIDA) , University of Colorado
Synopsis: To compare the clinical efficacy of daily vs. 3-day (MWF) buprenorphine/naloxone combination tablet administration and determine whether outcomes are improved when using a 3-day schedule in which all doses are ingested at the clinic vs. one in which take-home doses are given on intervening days.
Details: Mon/Wed/Fri dosing with the 8 mg buprenorphine/naloxone tablet is as safe and effective as daily dosing and is preferred by patients to daily dosing. Multiple doses of the combination tabelt (e.g. 16mg, 24mg) are well tolerated by patients. A 3 day schedule with take-outs is as effective as a 3-day schedule in which all medication is ingested at the clinic
Eligibility:
Study Type:  Interventional, Treatment, Double-Blind, Uncontrolled, Crossover Assignment
Minimum Age/Maximum Age: 18 Years/62 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: Individual must be currently dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency. Exclusion Criteria: Individuals with evidence of an active DSM-IV Axis I psychiatric disorder (e.g., psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.
Total Enrollment: 0

Location and Contact Information:

Overall Study Official:
LeslieAmass,  Principal Investigator,  University of Colorado

University of Colorado Health Sciences Center
Denver,  Colorado,  80206
United States
 


Additional Information:
Study ID Numbers:  NIDA-11160-2;  R01-11160-2
Study Start Date: June 1997
Record last reviewed: November 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000327

Other Heroin Dependence Studies:
1. Role of Instructions in Nitrous Oxide Effects and Choice - 10

2. A Phase III Placebo-Controlled, Double-Blind Multi-Site Trial of Lofexidine for Opiate Withdrawal - 1

3. Safety Evaluation of Lofexidine for Treatment of Opioid Withdrawal - 7

4. Effects of Subanesthetic Concentrations of Nitrous Oxide - 1

5. PK 0396 - Buprenorphine Dose Escalation Trial - 2

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