NCT00000244

Brief Summary

The purpose of this study is to evaluate the effects of IV dynorphin in humans during acute heroin abstinence, in order to determine that dynorphin suppresses acute opiate withdrawal, reduces opiate craving, and is safe at doses required to produce the above effects.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Aug 1994

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1994

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 1997

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 1997

Completed
2.6 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

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

2.6 years

First QC Date

September 20, 1999

Last Update Submit

May 26, 2015

Conditions

Opioid-Related DisordersSubstance Withdrawal Syndrome

Keywords

addictionopiateheroindynorphin

Outcome Measures

Primary Outcomes (1)

  • Craving scale

Interventions

Dynorphin 1 - 13DRUG

Eligibility Criteria

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

You may qualify if:

  • opiate addict between the ages of 18-55

You may not qualify if:

  • Regular abuse of other drugs, unstable medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U of Minnesota School of Medicine

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (1)

  • Specker S, Wananukul W, Hatsukami D, Nolin K, Hooke L, Kreek MJ, Pentel PR. Effects of dynorphin A(1-13) on opiate withdrawal in humans. Psychopharmacology (Berl). 1998 Jun;137(4):326-32. doi: 10.1007/s002130050626.

    PMID: 9676891BACKGROUND

MeSH Terms

Conditions

Opioid-Related DisordersSubstance Withdrawal SyndromeBehavior, AddictiveSpinocerebellar ataxia 23

Interventions

dynorphin (1-13)

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Paul Pentel, M.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

August 1, 1994

Primary Completion

March 1, 1997

Study Completion

March 1, 1997

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

US(1)