New Approaches to Cocaine Abuse Medications (A) - 6

New York State Psychiatric Institute

Status and phase: Completed; Phase 2

Conditions: Substance-Related Disorders; Cocaine-Related Disorders

Treatments: Drug: Placebo; Drug: Desipramine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00000271

3881

5P50DA009236-18 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to measure the effect of desipramine in cocaine abusers selected for major depression or dysthymia.

Full description

This is a randomized, 12-week, double-blind, 'placebo-controlled trial of outpatients meeting DSM-III-R criteria for cocaine dependence and major depression or dysthymia (by SCID interview). Participants were treated with desipramine, up to 300 mg per day, or matching placebo. All patients received weekly individual manual-guided relapse prevention therapy. Weekly outcome measures included the Clinical Global Impression Scale, self-reported cocaine use and craving, urine toxicology, and the Hamilton Depression Scale.

Enrollment: 111 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 2 patient groups, including a placebo group

Desipramine

Experimental group

Description:

Participants were treated with desipramine, up to 300 mg per day. All patients received weekly individual manual-guided relapse prevention therapy.

Treatment:

Drug: Desipramine

Placebo

Placebo Comparator group

Description:

Participants were treated with matching placebo. All patients received weekly individual manual-guided relapse prevention therapy.

Treatment:

Drug: Placebo