ClinicalTrials.gg
CompletedNCT00000273Updated Jul 5, 2017

A Laboratory Model for Heroin Abuse Medications - 8

A Phase 2 interventional study of opiates in Heroin Dependence, Opioid-Related Disorders and Substance-Related Disorders, sponsored by New York State Psychiatric Institute. Completed at 2 sites in United States. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2017-07-05.

Sponsored by New York State Psychiatric Institute · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2005, 21 years ago, and no results have been posted to the registry.
Phase
Phase 2
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
01

Study 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."

Read the detailed description

Abuse of prescription opioid medications has increased dramatically in the U.S. during the past decade, as indicated by a variety of epidemiological sources. However, few studies have systematically examined the relative reinforcing effects of commonly abused opioid medications. The current inpatient study was designed to compare the effects of intravenously delivered fentanyl , oxycodone, morphine, buprenorphine and heroin in morphine-maintained heroin abusers. All of the participants received all of the drugs tested; drugs and doses were administered in non-systematic order.

02

Conditions studied

  • Heroin Dependence
  • Opioid-Related Disorders
  • Substance-Related Disorders

Keywords

  • heroin, opioid disorders, substance related disorders
03

In context

Heroin Dependence

90 studies on the registry are indexed under Heroin Dependence; 1 is open to participants now.

This study's enrollment of 8 is below the median of 87 across 57 interventional studies indexed under Heroin Dependence.

Browse Heroin Dependence studies →

Lead sponsor

New York State Psychiatric Institute is the lead sponsor of 435 studies on the registry; 27 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 45 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  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 criteria

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 or SGPT > 3 times normal
  9. Significant suicide risk
  10. Current or history of chronic pain
  11. Sensitivity, allergy, or to opioids
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Opiates

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

    Drug: opiates

Interventions

  • Drugopiates

    prescription opioids

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

06

What researchers measure

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..

    Time frame: 90 minutes

Secondary outcomes

  1. Subjective responses

    Four questionnaires were used to assess subjective effects

    Time frame: 90 min

07

Study locations

2 sites
  • Columbia University
    New York, New York 10032, United States
  • New York State Psychiatric Institute
    New York, New York 10032, United States
08

References and documents

Publications

  • 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. PubMed 17581533 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 1995, a primary completion of Nov 2005 and a completion of Nov 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 1999
First posted
Sep 21, 1999
Start
Aug 1995
Primary completionActual
Nov 2005
CompletionActual
Nov 2005
Last update
Jul 5, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00000273
Responsible party
Sponsor
First posted
Sep 21, 1999
Start date
Aug 1995
Primary completion
Nov 2005
Completion
Nov 2005
Last update
Jul 5, 2017

Study contacts

Herbert Kleber, M.D.
principal investigator · New York State Psychiatric Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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