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Search / Trial NCT00000271

New Approaches to Cocaine Abuse Medications (A) - 6

Launched by NEW YORK STATE PSYCHIATRIC INSTITUTE · Sep 20, 1999

Trial Information

Current as of June 12, 2025

Completed

Keywords

Desipramine, Cocaine, Depression

ClinConnect Summary

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.

Gender

ALL

Eligibility 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.

About New York State Psychiatric Institute

The New York State Psychiatric Institute (NYSPI) is a leading research organization dedicated to advancing the understanding and treatment of mental health disorders. Affiliated with Columbia University, NYSPI integrates clinical research with cutting-edge scientific inquiry to develop innovative therapeutic strategies and improve patient care. With a focus on a wide range of psychiatric conditions, NYSPI conducts clinical trials that aim to translate findings from laboratory research into effective interventions, enhancing the quality of life for individuals affected by mental illness. Committed to ethical research practices and collaboration, NYSPI plays a pivotal role in shaping the future of psychiatric care through rigorous scientific exploration and community engagement.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Herbert Kleber, M.D.

Principal Investigator

New York State Psychiatric Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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