New Approaches to Cocaine Abuse Medications (A) - 6

New Approaches to Cocaine Abuse Medications (A)

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

Study Overview

• Status: Completed
• Conditions: Substance-Related Disorders; Cocaine-Related Disorders
• Intervention / Treatment: Drug: Desipramine; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Research Foundation for Mental Hygiene

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: National Institute on Drug Abuse (NIDA)

Publications and helpful links

General Publications

• McDowell D, Nunes EV, Seracini AM, Rothenberg J, Vosburg SK, Ma GJ, Petkova E. Desipramine treatment of cocaine-dependent patients with depression: a placebo-controlled trial. Drug Alcohol Depend. 2005 Nov 1;80(2):209-21. doi: 10.1016/j.drugalcdep.2005.03.026.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 1995
• Primary Completion (Actual): October 1, 2002
• Study Completion (Actual): October 1, 2002

Study Registration Dates

• First Submitted: September 20, 1999
• First Submitted That Met QC Criteria: September 20, 1999
• First Posted (Estimate): September 21, 1999

Study Record Updates

• Last Update Posted (Actual): July 5, 2017
• Last Update Submitted That Met QC Criteria: July 3, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Desipramine, cocaine, depression
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Disease; Cocaine-Related Disorders; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Tricyclic; Adrenergic Uptake Inhibitors; Desipramine
• Other Study ID Numbers: 3881; 5P50DA009236-18 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No