A Laboratory Model for Heroin Abuse Medications - 8
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00000273 |
Recruitment Status :
Completed
First Posted : September 21, 1999
Last Update Posted : July 5, 2017
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Condition or disease | Intervention/treatment | Phase |
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Heroin Dependence Opioid-Related Disorders Substance-Related Disorders | Drug: opiates | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Laboratory Model for Heroin Abuse Medications |
Study Start Date : | August 1995 |
Actual Primary Completion Date : | November 2005 |
Actual Study Completion Date : | November 2005 |

Arm | Intervention/treatment |
---|---|
Experimental: Opiates
Opiate-dependent individuals who were currently not seeking treatment for their drug use, completed the 6-week protocol.
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Drug: opiates
prescription opioids
Other Names:
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- Amount drug self-administered [ Time Frame: 90 minutes ]All of the participants received all of the drugs tested; drugs and doses were administered in non-systematic order. Participants were instructed to choose between the dose that they had received during the sample session or another reward..
- Subjective responses [ Time Frame: 90 min ]Four questionnaires were used to assess subjective effects

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criterion
- DSM IV criteria for opioid dependence
- No major mood, psychotic, or anxiety disorder
- Physically healthy
- Able to perform study procedures
- 21-45 years of age
- Current use of i.v. heroin in amounts/frequencies
- Not seeking treatment for opioid dependence
Exclusion Criterion
- DSM IV criteria for dependence on drugs other
- Participants requesting treatment
- Participants on parole or probation
- Pregnancy or lactation
- Birth, miscarriage or abortion with 6 months
- Recent history of or current significant violent behavior
- Current major Axis I psychopathology, other than heroin dependence ( e.g., mood disorder with functional impairment or suicide risk, schizophrenia), which might interfere with ability to participate in the study
- Hepatitis with SGOT or SGPT > 3 times normal
- Significant suicide risk
- Current or history of chronic pain
- Sensitivity, allergy, or contraindication to opioids

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000273
United States, New York | |
Columbia University | |
New York, New York, United States, 10032 | |
New York State Psychiatric Institute | |
New York, New York, United States, 10032 |
Principal Investigator: | Herbert Kleber, M.D. | New York State Psychiatric Institute |
Responsible Party: | New York State Psychiatric Institute |
ClinicalTrials.gov Identifier: | NCT00000273 |
Other Study ID Numbers: |
#4857/5982R 5P50DA009236-18 ( U.S. NIH Grant/Contract ) |
First Posted: | September 21, 1999 Key Record Dates |
Last Update Posted: | July 5, 2017 |
Last Verified: | June 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
heroin, opioid disorders, substance related disorders |
Disease Substance-Related Disorders Opioid-Related Disorders Heroin Dependence Pathologic Processes Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Fentanyl Morphine Oxycodone Buprenorphine Methadone Analgesics, Opioid |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics Narcotic Antagonists Antitussive Agents Respiratory System Agents |