New Approaches to Cocaine Abuse Medications (A) - 6

Study Overview
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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.

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.

Official Title
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New Approaches to Cocaine Abuse Medications (A)

Conditions
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Cocaine-Related Disorders, Substance-Related Disorders

Intervention / Treatment
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* Drug: Desipramine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion: Meets DSM-IV criteria for current cocaine dependence. Used cocaine at least one day in the past month. Currently meets DSM-IV criteria for Major Depression or Dysthymia. Depressive disorder is either: primary (antedates earliest lifetime substance abuse or persistent during 6 months of abstinence in the past or at least 3 months duration in the current episode Age 18-60. Able to give informed consent and comply with study procedures. Exclusion: Meets DSM-IV criteria for past mania (i.e. bipolar disorder), schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse. History of seizures. History of allergic reaction to desipramine or imipramine. Chronic organic mental disorder. Significant current suicidal risk. Pregnancy, lactation or failure in sexually active female patients to use adequate contraceptive methods. Unstable physical disorders which might make participation hazardous such as hypertension, hepatitis or diabetes. Coronary vascular disease as indicated by history or suspected by abnormal ECG or history or cardiac symptoms. Cardiac conduction system disease as indicated by QRS duration >0.11. Current use of other prescribed psychotropic medications within the last 2 weeks. History of failure to respond to a previous adequate trial of desipramine or another tricyclic antidepressant. Currently meets criteria for another substance dependence disorder (DSM-IV) other than nicotine, marijuana or alcohol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desipramine<br>Participants were treated with desipramine, up to 300 mg per day. All patients received weekly individual manual-guided relapse prevention therapy. | Drug: Desipramine<br>* Participants were treated with desipramine, up to 300 mg per day, or matching placebo. All participants received weekly individual manual-guided relapse prevention therapy.<br>* Other names: desmethylimipramine;|
| Placebo Comparator: Placebo<br>Participants were treated with matching placebo. All patients received weekly individual manual-guided relapse prevention therapy. | Drug: Placebo<br>* Participants were treated with matching placebo. All participants received weekly individual manual-guided relapse prevention therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cocaine Use | Clinical Global Impression Scale, self-reported cocaine use and craving, urine toxicology. | Weekly over a 12 week period. | 
| Depression | Hamilton Depression Scale | Bi-weekly over a 12 week period. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Desipramine, cocaine, depression