Back to results

Effects of Dynorphin 1-13 on Heroin Addiction - 1

Primary Purpose

Opioid-Related Disorders, Substance Withdrawal Syndrome

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Dynorphin 1 - 13

About this trial

This is an interventional treatment trial for Opioid-Related Disorders focused on measuring addiction, opiate, heroin, dynorphin

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: opiate addict between the ages of 18-55 Exclusion Criteria: Regular abuse of other drugs, unstable medical conditions

Sites / Locations

U of Minnesota School of Medicine

Outcomes

Primary Outcome Measures

Craving scale

Secondary Outcome Measures

Full Information

NCT ID

NCT00000244

First Posted

September 20, 1999

Last Updated

May 26, 2015

Sponsor

University of Minnesota

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT00000244

Brief Title

Effects of Dynorphin 1-13 on Heroin Addiction - 1

Official Title

Effects of Dynorphin 1-13 on Heroin Addiction

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

August 1994 (undefined)

Primary Completion Date

March 1997 (Actual)

Study Completion Date

March 1997 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid-Related Disorders, Substance Withdrawal Syndrome

Keywords

addiction, opiate, heroin, dynorphin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

Double

Enrollment

0 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Dynorphin 1 - 13

Primary Outcome Measure Information:

Title

Craving scale

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: opiate addict between the ages of 18-55 Exclusion Criteria: Regular abuse of other drugs, unstable medical conditions

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Pentel, M.D.

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

U of Minnesota School of Medicine

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55415

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

9676891

Citation

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.

Results Reference

background

Learn more about this trial

Effects of Dynorphin 1-13 on Heroin Addiction - 1

We'll reach out to this number within 24 hrs