Effects of Dynorphin 1-13 on Heroin Addiction - 1

This study has been completed.

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) University of Minnesota
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000244

Purpose

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.

Condition	Intervention	Phase
Opioid-Related Disorders Substance Withdrawal Syndrome	Drug: Dynorphin 1 - 13	Phase II

MedlinePlus related topics: Heroin

Drug Information available for: Diacetylmorphine Diacetylmorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Placebo Control
Official Title:	Effects of Dynorphin 1-13 on Heroin Addiction

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Wang withdrawal score
Subjective agonist/antagonist scale
Observer withdrawal checklist
Craving scale

Estimated Enrollment:	0
Study Start Date:	August 1994

Detailed 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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

opiate addict between the ages of 18-55

Exclusion Criteria:

Regular abuse of other drugs, unstable medical conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000244

Locations

United States, Minnesota
U of Minnesota School of Medicine
Minneapolis, Minnesota, United States, 55415

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

University of Minnesota

Investigators

Principal Investigator:

Paul Pentel, M.D.

University of Minnesota

More Information

Publications:

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.

Study ID Numbers:	NIDA-08067-1, R01-08067-1
Study First Received:	September 20, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000244
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Behavior, Addictive
Substance Withdrawal Syndrome
Heroin
Mental Disorders
Heroin Dependence

Substance-Related Disorders
Disorders of Environmental Origin
Opioid-Related Disorders
Dynorphins

Additional relevant MeSH terms:

Neurotransmitter Agents
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action

Syndrome
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009