NCT00000273

Brief Summary

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."

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 1995

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1995

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

September 20, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 1999

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

July 5, 2017

Status Verified

June 1, 2017

Enrollment Period

10.3 years

First QC Date

September 20, 1999

Last Update Submit

July 3, 2017

Conditions

Heroin DependenceOpioid-Related DisordersSubstance-Related Disorders

Keywords

heroin, opioid disorders, substance related disorders

Outcome Measures

Primary Outcomes (1)

  • Amount drug self-administered

    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..

    90 minutes

Secondary Outcomes (1)

  • Subjective responses

    90 min

Study Arms (1)

Opiates

EXPERIMENTAL

Opiate-dependent individuals who were currently not seeking treatment for their drug use, completed the 6-week protocol.

Drug: opiates

Interventions

opiatesDRUG

prescription opioids

Also known as: morphine, fentanyl, buprenorphine, oxycodone, methadone
Opiates

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Inclusion Criterion 1. DSM IV criteria for opioid dependence 2. No major mood, psychotic, or anxiety disorder 3. Physically healthy 4. Able to perform study procedures 5. 21-45 years of age 6. Current use of i.v. heroin in amounts/frequencies 7. Not seeking treatment for opioid dependence Exclusion Criterion 1. DSM IV criteria for dependence on drugs other 2. Participants requesting treatment 3. Participants on parole or probation 4. Pregnancy or lactation 5. Birth, miscarriage or abortion with 6 months 6. Recent history of or current significant violent behavior 7. 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 8. Hepatitis with SGOT or SGPT \> 3 times normal 9. Significant suicide risk 10. Current or history of chronic pain 11. Sensitivity, allergy, or contraindication to opioids

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Columbia University

New York, New York, 10032, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

  • Comer SD, Sullivan MA, Whittington RA, Vosburg SK, Kowalczyk WJ. Abuse liability of prescription opioids compared to heroin in morphine-maintained heroin abusers. Neuropsychopharmacology. 2008 Apr;33(5):1179-91. doi: 10.1038/sj.npp.1301479. Epub 2007 Jun 20.

    PMID: 17581533RESULT

MeSH Terms

Conditions

Heroin DependenceOpioid-Related DisordersSubstance-Related Disorders

Interventions

Opiate AlkaloidsMorphineFentanylBuprenorphineOxycodoneMethadone

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic CompoundsMorphine DerivativesMorphinansHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsPiperidinesHeterocyclic Compounds, 1-RingCodeineKetonesOrganic Chemicals

Study Officials

  • Herbert Kleber, M.D.

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

August 1, 1995

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

July 5, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)