The purpose of this study is 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.

Condition	Treatment or Intervention	Phase
Heroin Dependence Opioid-Related Disorders	Drug: Heroin Dependence	Phase II

Further Study 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

Ages Eligible for Study:  18 Years   -   62 Years,  Genders Eligible for Study:  Both

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.

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

Study chairs or principal investigators

Leslie Amass, Ph.D.,  Principal Investigator,  University of Colorado   

Study ID Numbers:  NIDA-11160-2; R01-11160-2
Record last reviewed:  November 1997
Last Updated:  February 16, 2005
Record first received:  September 20, 1999
ClinicalTrials.gov Identifier:  NCT00000327
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08