Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-1 - 4

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00000329
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 0
• Location: 1
• Duration (Months): 4
• Patients Per Site Per Month: 0

Study Details

Study Description

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 buprenorphine-naloxone maintained volunteers

Condition or Disease	Intervention/Treatment	Phase
Heroin Dependence; Opioid-Related Disorders	Drug: Opioid-Related Disorders	Phase 2

Detailed Description

Ongoing study - results not available at this time

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-1
• Study Start Date: Apr 1, 1999
• Actual Primary Completion Date: Aug 1, 1999
• Actual Study Completion Date: Aug 1, 1999

Outcome Measures

Primary Outcome Measures

1. Subjective dose estimate []

2. Observed withdrawal rating []

3. Opioid agonist rating []

4. Opioid antagonist rating []

5. Pupil diameter []

6. Analog rating scale for drug effects []

7. Drug effect characteristics []

8. Drug/Money Preferences []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Individuals must be at least 18 yrs of age, 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 and have a history of IV opioid use.

Exclusion Criteria:

Individuals with evidence of anti 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT00000329
• Other Study ID Numbers: NIDA-11160-4; R01DA011160; R01-11160-4
• First Posted: Sep 21, 1999
• Last Update Posted: May 4, 2017
• Last Verified: May 1, 2017

• Keywords provided by University of Colorado, Denver: drug dependence
• Additional relevant MeSH terms: Opioid-Related Disorders; Heroin Dependence; Analgesics, Opioid

Study Results

No Results Posted as of May 4, 2017