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New Approaches to Cocaine Abuse Medications (A) - 6

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00000271
First received: September 20, 1999
Last updated: July 3, 2017
Last verified: June 2017
  Purpose
The purpose of this study is to measure the effect of desipramine in cocaine abusers selected for major depression or dysthymia.

Condition Intervention Phase
Cocaine-Related Disorders Substance-Related Disorders Drug: Desipramine Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: New Approaches to Cocaine Abuse Medications (A)

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Cocaine Use [ Time Frame: Weekly over a 12 week period. ]
    Clinical Global Impression Scale, self-reported cocaine use and craving, urine toxicology.

  • Depression [ Time Frame: Bi-weekly over a 12 week period. ]
    Hamilton Depression Scale


Enrollment: 111
Actual Study Start Date: January 1995
Study Completion Date: October 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000271

Locations
United States, New York
Research Foundation for Mental Hygiene
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Herbert Kleber, M.D. New York State Psychiatric Institute
  More Information

Publications:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00000271     History of Changes
Other Study ID Numbers: 3881
5P50DA009236-18 ( U.S. NIH Grant/Contract )
Study First Received: September 20, 1999
Last Updated: July 3, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by New York State Psychiatric Institute:
Desipramine, cocaine, depression

Additional relevant MeSH terms:
Disease
Substance-Related Disorders
Cocaine-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Cocaine
Desipramine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on July 24, 2017