Overview

New Approaches to Cocaine Abuse Medications (A) - 6

Status:
Completed
Trial end date:
2002-10-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to measure the effect of desipramine in cocaine abusers selected for major depression or dysthymia.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
New York State Psychiatric Institute
Collaborators:
National Institute on Drug Abuse (NIDA)
New York State Psychiatric Institute
Treatments:
Cocaine
Desipramine
Criteria
Inclusion:

1. Meets DSM-IV criteria for current cocaine dependence.

2. Used cocaine at least one day in the past month.

3. Currently meets DSM-IV criteria for Major Depression or Dysthymia.

4. Depressive disorder is either:

1. primary (antedates earliest lifetime substance abuse or

2. persistent during 6 months of abstinence in the past or

3. at least 3 months duration in the current episode

5. Age 18-60.

6. Able to give informed consent and comply with study procedures.

Exclusion:

1. Meets DSM-IV criteria for past mania (i.e. bipolar disorder), schizophrenia or any
psychotic disorder other than transient psychosis due to drug abuse.

2. History of seizures.

3. History of allergic reaction to desipramine or imipramine.

4. Chronic organic mental disorder.

5. Significant current suicidal risk.

6. Pregnancy, lactation or failure in sexually active female patients to use adequate
contraceptive methods.

7. Unstable physical disorders which might make participation hazardous such as
hypertension, hepatitis or diabetes.

8. Coronary vascular disease as indicated by history or suspected by abnormal ECG or
history or cardiac symptoms.

9. Cardiac conduction system disease as indicated by QRS duration >0.11.

10. Current use of other prescribed psychotropic medications within the last 2 weeks.

11. History of failure to respond to a previous adequate trial of desipramine or another
tricyclic antidepressant.

12. Currently meets criteria for another substance dependence disorder (DSM-IV) other than
nicotine, marijuana or alcohol.