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A Laboratory Model for Heroin Abuse Medications - 8

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
New York State Psychiatric Institute
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00000273
First received: September 20, 1999
Last updated: July 8, 2009
Last verified: July 2009
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Laboratory Model for Heroin Abuse Medications

Resource links provided by NLM:

MedlinePlus related topics: Heroin
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
Experimental: Opiate abuser Drug: opiates
prescription opioids
Other Names:
  • morphine
  • fentanyl
  • buprenorphine
  • oxycodone
  • methadone

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

Additional relevant MeSH terms:
Opioid-Related Disorders
Heroin Dependence
Substance-Related Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on May 19, 2013