Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-2 - 5

This study has been terminated.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00000330
First received: September 20, 1999
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to assess the abuse liability and reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in heroin-dependent volunteers


Condition Intervention Phase
Heroin Dependence
Opioid-Related Disorders
Drug: Opioid-Related Disorders
Phase 2

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-2

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Subjective dose estimate
  • Observed withdrawal rating
  • Opioid antagonist rating
  • Pupil diameter
  • Analog rating scale for drug effects
  • Drug effect characteristics
  • Drug/Money Preferences

Estimated Enrollment: 0
Study Start Date: October 1999
Study Completion Date: November 1999
Primary Completion Date: November 1999 (Final data collection date for primary outcome measure)
Detailed Description:

not available at this time

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Individuals must be at least 18 yrs of age, currently opioid dependent and must not be seeking treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency and have a history of IV opioid use.

Exclusion Criteria:

Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000330

Locations
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80206
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Leslie Amass, Ph.D. University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00000330     History of Changes
Other Study ID Numbers: NIDA-11160-5, R01DA011160, R01-11160-5
Study First Received: September 20, 1999
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Naloxone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on April 22, 2014