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NCT00000244 Clinical Trial

Effects of Dynorphin 1-13 on Heroin Addiction - 1

Opioid-Related Disorders Clinical Trial

Official title:
Effects of Dynorphin 1-13 on Heroin Addiction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000244
Other study ID # NIDA-08067-1
Secondary ID R01DA008067R01-0
Status Completed
Phase Phase 2
First received September 20, 1999
Last updated May 26, 2015
Start date August 1994
Est. completion date March 1997

Study information
Verified date May 2015
Source University of Minnesota - Clinical and Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

Description:

Randomized double blinded study of the effects of a single IV dose of dynorphin A 1-13 on heroin withdrawal in human opiate addicts

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date March 1997
Est. primary completion date March 1997
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

opiate addict between the ages of 18-55

Exclusion Criteria:

Regular abuse of other drugs, unstable medical conditions

Study Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Dynorphin 1 - 13

Locations
Country Name City State
United States U of Minnesota School of Medicine Minneapolis Minnesota

Sponsors (2)
Lead Sponsor Collaborator
University of Minnesota - Clinical and Translational Science Institute National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Craving scale
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