New Approaches to Cocaine Abuse Medications (A) - 6

Substance-Related Disorders Clinical Trial

Official title:

New Approaches to Cocaine Abuse Medications (A)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000271
• Other study ID #: 3881
• Secondary ID: 5P50DA009236-18
• Status: Completed
• Phase: Phase 2
• First received: September 20, 1999
• Last updated: July 3, 2017
• Start date: January 1995
• Est. completion date: October 2002

Study information

• Verified date: June 2017
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: October 2002
• Est. primary completion date: October 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cocaine-Related Disorders
• Disease
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Research Foundation for Mental Hygiene	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cocaine Use	Clinical Global Impression Scale, self-reported cocaine use and craving, urine toxicology.	Weekly over a 12 week period.
Primary	Depression	Hamilton Depression Scale	Bi-weekly over a 12 week period.