NCT00142727

TerminatedPhase 2

Opioid Agonist and Antagonist Effects on Opioid Dependence

National Institute on Drug Abuse (NIDA)Source

National Institute on Drug Abuse (NIDA)

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

NIDA-08045-6

Secondary identifiers

R01-08045-6

DPMC

Study Type

interventional

Estimated enrollment

16

Locations

1 country

Sites

1

Timeline

Study Start

January 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

February 2006

Date type not reported

This date has not been verified as actual or estimated.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Estimated enrollment: 16 participants
Study completion date: February 2006
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2004
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 1, 2005
Actual (reported)
First Posted
September 2, 2005
Actual (reported)
Study Completion
February 2006
Date type not reported
This date has not been verified as actual or estimated.

Last Updated: January 12, 2017
Status Verified: July 2007
Last Update Submitted: 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

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)

Sponsors & Collaborators

National Institute on Drug Abuse (NIDA)
NIHlead
Johns Hopkins University
Othercollaborator

Study Sites (1)

Johns Hopkins University (BPRU) Bayview Campus

Baltimore, Maryland, 21224 6823, United States

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 Depressants

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 2004

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

February 2006

Date type not reported

NCT00000344

Buprenorphine/Naloxone for Treatment of Opiate Dependence - 9

Phase 2Completed

NCT00000238

Temporal Discounting Delayed Outcomes on Opioid-Dependent Outpatients - 20

Phase 2Completed

NCT00000223

Alternate-Day Buprenorphine Administration. Phase IV - 5

Phase 2Completed

NCT00000225

Alternate-Day Buprenorphine Administration. Phase VI - 7

Phase 2Completed

NCT00000226

Alternate-Day Buprenorphine Administration. Phase VII - 8

Phase 2Completed

NCT00000239

Buprenorphine Pharmacology Related to Addiction Treatment - 21

Phase 2Completed

Opioid antagonistDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

Physiological Effects of Drugs

Pharmacologic Actions

Chemical Actions and Uses

Analgesics

Sensory System Agents

Peripheral Nervous System Agents

Central Nervous System Agents

Therapeutic Uses

This date has not been verified as actual or estimated.

Last Updated

January 12, 2017

Record last verified: 2007-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00142727
Data provider: ClinicalTrials.gov
Source updated: 2017-01-12
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:39 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations