Clinical trial NCT00000271: New Approaches to Cocaine Abuse Medications (A) - 6
Official title: New Approaches to Cocaine Abuse Medications (A)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Substance-Related Disorders
Keywords: Desipramine, cocaine, depression
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cocaine Use
timeFrame: Weekly over a 12 week period.
measure: Depression
timeFrame: Bi-weekly over a 12 week period.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Research Foundation for Mental Hygiene
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Herbert Kleber, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.