- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000244
Effects of Dynorphin 1-13 on Heroin Addiction - 1
May 26, 2015 updated by: University of Minnesota
Effects of Dynorphin 1-13 on Heroin Addiction
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.
Study Overview
Status
Completed
Intervention / Treatment
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
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55415
- U of Minnesota School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
opiate addict between the ages of 18-55
Exclusion Criteria:
Regular abuse of other drugs, unstable medical conditions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Craving scale
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul Pentel, M.D., University of Minnesota
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 1994
Primary Completion (Actual)
March 1, 1997
Study Completion (Actual)
March 1, 1997
Study Registration Dates
First Submitted
September 20, 1999
First Submitted That Met QC Criteria
September 20, 1999
First Posted (Estimate)
September 21, 1999
Study Record Updates
Last Update Posted (Estimate)
May 27, 2015
Last Update Submitted That Met QC Criteria
May 26, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Compulsive Behavior
- Impulsive Behavior
- Opioid-Related Disorders
- Heroin Dependence
- Behavior, Addictive
- Substance Withdrawal Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Dynorphins
Other Study ID Numbers
- NIDA-08067-1
- R01DA008067 (U.S. NIH Grant/Contract)
- R01-08067-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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