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New Approaches to Cocaine Abuse Medications (A) - 6

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ClinicalTrials.gov Identifier: NCT00000271
Recruitment Status : Completed
First Posted : September 21, 1999
Last Update Posted : July 5, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute

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

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Substance-Related Disorders Drug: Desipramine Drug: Placebo Phase 2

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  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: New Approaches to Cocaine Abuse Medications (A)
Actual Study Start Date : January 1995
Primary Completion Date : October 2002
Study Completion Date : October 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 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.



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

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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 )
First Posted: September 21, 1999    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: June 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