NCT00000271

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 1995

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1995

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 20, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 1999

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2002

Completed
Last Updated

July 5, 2017

Status Verified

June 1, 2017

Enrollment Period

7.8 years

First QC Date

September 20, 1999

Last Update Submit

July 3, 2017

Conditions

Cocaine-Related DisordersSubstance-Related Disorders

Keywords

Desipramine, cocaine, depression

Outcome Measures

Primary Outcomes (2)

  • Cocaine Use

    Clinical Global Impression Scale, self-reported cocaine use and craving, urine toxicology.

    Weekly over a 12 week period.

  • Depression

    Hamilton Depression Scale

    Bi-weekly over a 12 week period.

Study Arms (2)

Desipramine

EXPERIMENTAL

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

Drug: Desipramine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

DesipramineDRUG

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

Also known as: desmethylimipramine
Desipramine
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Foundation for Mental Hygiene

New York, New York, 10032, United States

Location

Related 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. doi: 10.1016/j.drugalcdep.2005.03.026.

    PMID: 15913920RESULT

MeSH Terms

Conditions

Cocaine-Related DisordersSubstance-Related DisordersDepression

Interventions

Desipramine

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Herbert Kleber, M.D.

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

January 1, 1995

Primary Completion

October 1, 2002

Study Completion

October 1, 2002

Last Updated

July 5, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)