NCT00000335

Brief Summary

The purpose of this study is to determine if hyperactivity accompanies abrupt opiate withdrawal in heroin addicts, to determine if computerized solid state activity monitors are capable of quantifying hyperactivity, and to quantify the physical and affective symptoms occurring during abrupt withdrawal in heroin addicts and morphine's capacity to alleviate these symptoms.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 1995

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

September 30, 1995

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 1996

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 1996

Completed
3.3 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
Last Updated

January 31, 2017

Status Verified

December 1, 2002

Enrollment Period

6 months

First QC Date

September 20, 1999

Last Update Submit

January 30, 2017

Conditions

Opioid-Related Disorders

Keywords

opioid dependence

Outcome Measures

Primary Outcomes (5)

  • Depression

  • Anxiety

  • Withdrawal severity

  • Activity

  • Opiate secondary withdrawal

Interventions

MorphineDRUG

Eligibility Criteria

Age21 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
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Sponsors & Collaborators

Study Sites (1)

Washington DC VA

Washington D.C., District of Columbia, 20422, United States

Location

Related Publications (1)

  • 1996 CPDD, NIDA Research Monograph

    BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Morphine

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Steven Deutsch, M.D.

    Washington D.C. Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

September 30, 1995

Primary Completion

March 20, 1996

Study Completion

May 20, 1996

Last Updated

January 31, 2017

Record last verified: 2002-12

Locations

US(1)