A Laboratory Model for Heroin Abuse Medications - 8

This study is currently recruiting participants.

Verified by National Institute on Drug Abuse (NIDA), July 2009

First Received: September 20, 1999 Last Updated: July 8, 2009 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	New York State Psychiatric Institute
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000273

Purpose

The purpose of this study is to evaluate the effects of treatment medications (methadone, buprenorphine, LAAM, naltrexone, naltrexone microcapsules, and methoclocinnamox) on I.V. and smoked heroin self-administration."

Condition	Intervention	Phase
Heroin Dependence Opioid-Related Disorders Substance-Related Disorders	Drug: opiates	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	A Laboratory Model for Heroin Abuse Medications

Resource links provided by NLM:

MedlinePlus related topics: Heroin

Drug Information available for: Diacetylmorphine Diacetylmorphine hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Amount drug self-administered [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subjective responses [ Time Frame: 90 min ] [ Designated as safety issue: No ]

Estimated Enrollment:	37
Study Start Date:	August 1995
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Opiate abuser: Experimental	Drug: opiates prescription opioids

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Please contact site for information.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000273

Contacts

Contact: Sandra D Comer, Ph.D.	212-543-5981	sdc10@columbia.edu
Contact: Phillip Saccone, BS	212-543-5319	saccone@pi.cpmc.columbia.edu

Locations

United States, New York
Columbia University	Recruiting
New York, New York, United States, 10032
Contact: Sandra D Comer, Ph.D. 212-543-5981 sdc10@columbia.edu
Contact: Phillip Saccone, BS 212-543-6243 saccone@pi.cpmc.columbia.edu

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

New York State Psychiatric Institute

Investigators

Principal Investigator:

Herbert Kleber, M.D.

New York State Psychiatric Institute

More Information

No publications provided

Responsible Party:	Columbia University and the New York State Psychiatric Institute ( Sandra D. Comer, PhD )
Study ID Numbers:	NIDA-09236-8, P50 DA009236-08
Study First Received:	September 20, 1999
Last Updated:	July 8, 2009
ClinicalTrials.gov Identifier:	NCT00000273 History of Changes
Health Authority:	United States: Federal Government; United States: Institutional Review Board; United States: Food and Drug Administration

Additional relevant MeSH terms:

Pathologic Processes
Disease
Mental Disorders
Heroin Dependence

Substance-Related Disorders
Disorders of Environmental Origin
Opioid-Related Disorders

ClinicalTrials.gov processed this record on February 08, 2010