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High Dose Nimodipine Treatment Adjunct - 1

Primary Purpose

Cocaine-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nimodipine
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine-Related Disorders

Eligibility Criteria

22 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Please contact site for information.

Sites / Locations

  • Washington DC VA

Outcomes

Primary Outcome Measures

Stimulated and non-stimulated craving
Stimulated and non-stimulated withdrawal
Anxiety, depression
Heart rate

Secondary Outcome Measures

Full Information

First Posted
September 20, 1999
Last Updated
February 23, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Washington D.C. Veterans Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00000332
Brief Title
High Dose Nimodipine Treatment Adjunct - 1
Official Title
High Dose Nimodipine Pharmacotherapy Adjunct
Study Type
Interventional

2. Study Status

Record Verification Date
December 2002
Overall Recruitment Status
Completed
Study Start Date
May 1998 (Actual)
Primary Completion Date
January 2000 (Actual)
Study Completion Date
April 2000 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Washington D.C. Veterans Affairs Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to determine if nimodipine is more effective than placebo in reducing stimulated craving for cocaine in cocaine dependent individuals denied access to cocaine in inpatient unit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
0 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nimodipine
Primary Outcome Measure Information:
Title
Stimulated and non-stimulated craving
Title
Stimulated and non-stimulated withdrawal
Title
Anxiety, depression
Title
Heart rate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Please contact site for information.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Deutsch, M.D.
Organizational Affiliation
Washington D.C. Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington DC VA
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States

12. IPD Sharing Statement

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High Dose Nimodipine Treatment Adjunct - 1

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