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WithdrawnNCT00000330Updated May 4, 2017

Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-2 - 5

A Phase 2 interventional study of Opioid-Related Disorders in Heroin Dependence and Opioid-Related Disorders, sponsored by University of Colorado, Denver. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-05-04.

Sponsored by University of Colorado, Denver · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
0
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to assess the abuse liability and reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in heroin-dependent volunteers

Read the detailed description

not available at this time

02

Conditions studied

  • Heroin Dependence
  • Opioid-Related Disorders

Keywords

  • Heroin Dependence
03

In context

Heroin Dependence

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

Browse Heroin Dependence studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.

Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 65 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

Individuals must be at least 18 yrs of age, currently opioid dependent and must not be seeking treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency and have a history of IV opioid use.

Exclusion criteria

Exclusion Criteria:

Individuals with evidence of an active (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.

Terms in these criteria, in plain language(1)

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.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
Double
Enrollment
0 participants (actual)

Interventions

  • DrugOpioid-Related Disorders
06

What researchers measure

Primary outcomes

  1. Subjective dose estimate

  2. Observed withdrawal rating

  3. Opioid antagonist rating

  4. Pupil diameter

  5. Analog rating scale for drug effects

  6. Drug effect characteristics

  7. Drug/Money Preferences

07

Study locations

1 site
  • University of Colorado Health Sciences Center
    Denver, Colorado 80206, United States
08

Timeline

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

The record gives a start of Oct 1999, a primary completion of Nov 1999 and a completion of Nov 1999. 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
Oct 1999
Primary completionActual
Nov 1999
CompletionActual
Nov 1999
Last update
May 4, 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 May 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00000330
Responsible party
Sponsor
First posted
Sep 21, 1999
Start date
Oct 1999
Primary completion
Nov 1999
Completion
Nov 1999
Last update
May 4, 2017

Study contacts

Leslie Amass, Ph.D.
principal investigator · University of Colorado, Denver
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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Discussion

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