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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00000331
Recruitment Status : Withdrawn
First Posted : September 21, 1999
Last Update Posted : May 4, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
The purpose of this study is to assess the abuse liability and examine the reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in healthy, non-drug dependent volunteers.

Condition or disease Intervention/treatment Phase
Heroin Dependence Opioid-Related Disorders Drug: Test Drug Drug: Placebo Drug Phase 2

Detailed Description:
not available at this time

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Masking: Double
Primary Purpose: Treatment
Official Title: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-3
Study Start Date : December 2002
Primary Completion Date : December 2002
Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heroin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Test Drug
Test drug to prevent heroine withdrawal
Drug: Test Drug
Other Name: test drug o
Placebo Comparator: Placebo Pill
Placebo drug
Drug: Placebo Drug



Primary Outcome Measures :
  1. Observed withdrawal rating
  2. Pupil diameter
  3. Drug effect characteristics


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Individuals must be healthy, non-drug dependent volunteers, be at least 18 years of age, and have no prior history of drug or alcohol abuse or dependence. Subjects must have had some minimal experience with opioids (e.g. at least two prior exposures)

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000331


Locations
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80206
Sponsors and Collaborators
University of Colorado, Denver
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Leslie Amass, Ph.D. University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00000331     History of Changes
Other Study ID Numbers: NIDA-11160-6
R01DA011160 ( U.S. NIH Grant/Contract )
R01-11160-6
First Posted: September 21, 1999    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017

Keywords provided by University of Colorado, Denver:
Heroin Dependence

Additional relevant MeSH terms:
Opioid-Related Disorders
Heroin Dependence
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists