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

Tracking Information

First Received Date ^ICMJE

September 20, 1999

Last Updated Date

November 3, 2005

Start Date ^ICMJE

April 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Subjective dose estimate
Observed withdrawal rating
Opioid agonist rating
Opioid antagonist rating
Pupil diameter
Analog rating scale for drug effects
Drug effect characteristics
Drug/Money Preferences

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00000329 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Ongoing study - results not available at this time

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Double-Blind, Placebo Control

Condition ^ICMJE

Heroin Dependence
Opioid-Related Disorders

Intervention ^ICMJE

Drug: Opioid-Related Disorders

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Individuals must be at least 18 yrs of age, currently opioid dependent and meet FDA critera 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 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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00000329

Responsible Party

Study ID Numbers ^ICMJE

NIDA-11160-4, R01-11160-4

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

University of Colorado at Denver and Health Sciences Center

Investigators ^ICMJE

Principal Investigator:

Leslie Amass, Ph.D.

University of Colorado at Denver and Health Sciences Center

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

April 1999

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP