Cocaine Effects in Humans: Physiology and Behavior - 1

Cocaine-Related Disorders Clinical Trial

Official title:

Cocaine Effects in Humans: Physiology and Behavior

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000200
• Other study ID #: NIDA-03818-1
• Secondary ID: R01-03818-1
• Status: Completed
• Phase: Phase 2
• First received: September 20, 1999
• Last updated: January 11, 2017
• Start date: January 1997
• Est. completion date: January 1998

Study information

• Verified date: October 2016
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effects of buprenorphine or methadone maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving, in opiate-dependent cocaine users.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 1998
• Est. primary completion date: January 1998
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years
• Eligibility: Please contact site for information.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-Related Disorders

Intervention

Drug:
• Methadone
normal maintenance dose

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Foltin RW, Fischman MW. Effects of methadone or buprenorphine maintenance on the subjective and reinforcing effects of intravenous cocaine in humans. J Pharmacol Exp Ther. 1996 Sep;278(3):1153-64. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interaction of cocaine and meds on cardio		3 hr	Yes
Primary	Interaction of cocaine & meds on coc's subjective		3 hr	Yes
Primary	Effects of medication on cocaine craving		3 hr	No