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New Approaches to Cocaine Abuse Medications (A) - 6

Primary Purpose

Cocaine-Related Disorders, Substance-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Desipramine
Placebo
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring Desipramine, cocaine, depression

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Foundation for Mental Hygiene

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Desipramine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cocaine Use
Clinical Global Impression Scale, self-reported cocaine use and craving, urine toxicology.
Depression
Hamilton Depression Scale

Secondary Outcome Measures

Full Information

First Posted
September 20, 1999
Last Updated
July 3, 2017
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000271
Brief Title
New Approaches to Cocaine Abuse Medications (A) - 6
Official Title
New Approaches to Cocaine Abuse Medications (A)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 1995 (Actual)
Primary Completion Date
October 2002 (Actual)
Study Completion Date
October 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders, Substance-Related Disorders
Keywords
Desipramine, cocaine, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desipramine
Arm Type
Experimental
Arm Description
Participants were treated with desipramine, up to 300 mg per day. All patients received weekly individual manual-guided relapse prevention therapy.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants were treated with matching placebo. All patients received weekly individual manual-guided relapse prevention therapy.
Intervention Type
Drug
Intervention Name(s)
Desipramine
Other Intervention Name(s)
desmethylimipramine
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Participants were treated with matching placebo. All participants received weekly individual manual-guided relapse prevention therapy.
Primary Outcome Measure Information:
Title
Cocaine Use
Description
Clinical Global Impression Scale, self-reported cocaine use and craving, urine toxicology.
Time Frame
Weekly over a 12 week period.
Title
Depression
Description
Hamilton Depression Scale
Time Frame
Bi-weekly over a 12 week period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert Kleber, M.D.
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Foundation for Mental Hygiene
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15913920
Citation
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.
Results Reference
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