NCT00142727

Brief Summary

The purpose of this study is to examine the acute agonist and antagonist effects of a full opioid agonist medication, an opioid antagonist medication, and a partial opioid agonist medication in individuals who have different levels of physical opioid dependence.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2004

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

January 12, 2017

Status Verified

July 1, 2007

First QC Date

September 1, 2005

Last Update Submit

January 11, 2017

Conditions

Opioid-Related Disorders

Outcome Measures

Primary Outcomes (3)

  • Opiate withdrawal

    up to one day

  • Opiate agonist symptoms

    up to one day

  • Physiologic measures

    up to one day

Interventions

MethadoneDRUG
Full opioid agonistDRUG
Partial opioid agonistDRUG
Opioid antagonistDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Active opioid dependence
  • Qualifies for opioid agonist treatment (e.g., methadone or buprenorphine)
  • Fulfills DSM-IV diagnostic criteria for opioid dependence

You may not qualify if:

  • Significant medical problems, including insulin dependent diabetes mellitus
  • Non-substance use psychiatric disorders (e.g., schizophrenia)
  • Currently seeking treatment for substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University (BPRU) Bayview Campus

Baltimore, Maryland, 21224 6823, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

MethadoneAnalgesics, OpioidNarcotic Antagonists

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

KetonesOrganic ChemicalsNarcoticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Eric C. Strain, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

January 1, 2004

Study Completion

February 1, 2006

Last Updated

January 12, 2017

Record last verified: 2007-07

Locations

US(1)