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CompletedNCT00033033Updated Jan 12, 2017

Reserpine for the Treatment of Cocaine Dependence - 1

A Phase 2 interventional study of Reserpine in Cocaine-Related Disorders and Substance-Related Disorders, sponsored by National Institute on Drug Abuse (NIDA). Completed at 3 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-01-12.

Sponsored by National Institute on Drug Abuse (NIDA) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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

Read the detailed description

To assess the efficacy and safety of reserpine in reducing cocaine use in subjects with cocaine dependence. This is a double-blind, placebo-controlled, parallel-group design with a 2 week baseline period.

02

Conditions studied

  • Cocaine-Related Disorders
  • Substance-Related Disorders

Keywords

  • cocaine dependence
03

In context

Cocaine-Related Disorders

415 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.

This study's enrollment of 140 is above the median of 60 across 312 interventional studies indexed under Cocaine-Related Disorders.

Browse Cocaine-Related Disorders studies →

Lead sponsor

National Institute on Drug Abuse (NIDA) is the lead sponsor of 388 studies on the registry; 19 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Additional criteria available during screening at the site.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
140 participants

Interventions

  • DrugReserpine
06

What researchers measure

Primary outcomes

  1. Cocaine use

  2. Addiction severity

  3. Cocaine withdrawal

  4. Adverse events

  5. Clinical improvement

07

Study locations

3 sites
  • Boston University Medical Center
    Boston, Massachusetts 02215, United States
  • Cincinnati VA Medical Center
    Cincinnati, Ohio 45220, United States
  • Dayton VA Medical Center
    Dayton, Ohio 45428, United States
08

References and documents

Publications

  • 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. PubMed 25969833 ↗
  • 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. PubMed 25938124 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00033033
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Cincinnati VA Medical Center
First posted
Apr 8, 2002
Start date
Jul 2001
Completion
May 2003
Last update
Jan 12, 2017

Study contacts

Eugene Somoza, M.D., Ph.D.
principal investigator · Cincinnati VA Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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