NCT00033033

Brief Summary

The purpose of this study is to assess the efficacy and safety of reserpine for the treatment of cocaine dependence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2001

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2002

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
Last Updated

January 12, 2017

Status Verified

August 1, 2008

First QC Date

April 5, 2002

Last Update Submit

January 11, 2017

Conditions

Cocaine-Related DisordersSubstance-Related Disorders

Keywords

cocaine dependence

Outcome Measures

Primary Outcomes (5)

  • Cocaine use

  • Addiction severity

  • Cocaine withdrawal

  • Adverse events

  • Clinical improvement

Interventions

ReserpineDRUG

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be at least 18 yrs of age; DSM-4 diagnosis of cocaine dependence; treatment seeking individuals; have the ability to understand and provide written informed consent; females of child bearing potential using appropriate birth control method

You may not qualify if:

  • Additional criteria available during screening at the site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Boston University Medical Center

Boston, Massachusetts, 02215, United States

Location

Cincinnati VA Medical Center

Cincinnati, Ohio, 45220, United States

Location

Dayton VA Medical Center

Dayton, Ohio, 45428, United States

Location

Related Publications (2)

  • Winhusen TM, Lewis DF, Somoza EC, Horn P. Pharmacodynamics must inform statistics: an example from a cocaine dependence pharmacotherapy trial. ISRN Addict. 2014 Feb 5;2014:927290. doi: 10.1155/2014/927290. eCollection 2014.

    PMID: 25969833DERIVED

  • Winhusen TM, Somoza EC, Lewis DF, Kropp F, Theobald J, Elkashef A. An Evaluation of Substance Abuse Treatment and HIV Education on Safe Sex Practices in Cocaine Dependent Individuals. ISRN Addict. 2014 Mar 4;2014:912863. doi: 10.1155/2014/912863. eCollection 2014.

    PMID: 25938124DERIVED

MeSH Terms

Conditions

Cocaine-Related DisordersSubstance-Related Disorders

Interventions

Reserpine

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

YohimbineSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Eugene Somoza, M.D., Ph.D.

    Cincinnati VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 5, 2002

First Posted

April 8, 2002

Study Start

July 1, 2001

Study Completion

May 1, 2003

Last Updated

January 12, 2017

Record last verified: 2008-08

Locations

US(3)