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Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1(1) - 1



Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1(1) - 1

For Condition: Heroin Dependence,Opioid-Related Disorders
Status: Completed
Sponsor(s): National Institute on Drug Abuse (NIDA) , University of Colorado
Synopsis: To assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen.
Details: Alternate-day dosing with the 8mg buprenorhpine-naloxone tablet is as safe and effective as daily dosing. Outcomes are improved when the total weekly dose provided druing alternate-day dosing is equal to that given during daily dosing.
Eligibility:
Study Type:  Interventional, Treatment, Double-Blind, Placebo Control, Crossover Assignment
Minimum Age/Maximum Age: 18 Years/64 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: Individuals must be currently opioid 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-11160-1;  R01-11160-1
Study Start Date: April 1997
Record last reviewed: August 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000326

Other Opioid-Related Disorders Studies:
1. CS1008 A&B Eff/Safety trial of BUP/NX for the Treatment of Opiate Dependence - 1

2. Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-3 - 6

3. Treatment Efficacy for Drug Abuse and AIDS Prevention - 2

4. Buprenorphine/Naloxone Treatment for Opiod Dependence-Experiment II-2 - 5

5. Buprenorphine/Naloxone versus Clonidine for Inpatient Opiate Detoxification - 1

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