New Approaches to Cocaine Abuse Medications (A) - 6

New York State Psychiatric Institute111 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

111

Conditions

Interventions

DesipramineDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Research Foundation for Mental Hygiene

New York, New York, United States

Outcomes

Primary Outcomes

Cocaine Use

Clinical Global Impression Scale, self-reported cocaine use and craving, urine toxicology.

Time frame: Weekly over a 12 week period.

Depression

Hamilton Depression Scale

Time frame: Bi-weekly over a 12 week period.

Data from ClinicalTrials.gov

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