New Approaches to Cocaine Abuse Medications (A)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-01-31

Study Completion Date

2002-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cocaine-Related Disorders Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Desipramine

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

Group Type EXPERIMENTAL

Desipramine

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Desipramine

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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desmethylimipramine

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No