Mirtazapine for Treating Cocaine Dependent Individuals Who Also Suffer From Depression

NCT00249444 | Completed Phase 2 Results DMC

• 4 other identifiers: 5086/6177R NIDA-09236-13P50DA009236P50DA009236-13DPMC
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Many substance dependent individuals also suffer from depression. Past research suggests that antidepressant medication is helpful in treating such individuals. This study will determine the effectiveness of mirtazapine, an antidepressant medication, in treating cocaine dependent individuals who also suffer from depression. This study includes free treatment for cocaine dependence that includes medication and a behavioral intervention.

Conditions

Cocaine Dependence; Depression

Keywords

cocaine dependence; mirtazipine

Outcome Measures

Primary Outcomes (2)

• Cocaine Abstinence During Last Three Weeks of Study

  measured daily by self report and confimed by urine toxicology for 8 weeks of the trial or length of study participation

  measured daily by self report and confimed by urine toxicology for 8 weeks of the trial or length of study participation

• Depression Score on Hamilton - Depression 25 Item

  Participants those who had a 50% decrease in HAM-D scores from baseline at end of study. The outcome measured is 50% drop in Hamilton score at week 8 or last week of study participation compared to baseline. We looked at the difference between baseline score and score at week 8 or last week of study participation.

  End of 8 week study or last week of participation

Study Arms (2)

Mirtazapine

ACTIVE COMPARATOR

Mirtazapine will be administered on a fixed-flexible schedule, with dose titrated up to 60 mg per day or the maximum tolerated dose.

Drug: Mirtazapine

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Mirtazapine DRUG

Mirtazapine

Also known as: Remeron

Mirtazapine

Placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Meets DSM-IV criteria for current cocaine dependence
• Currently seeking treatment for cocaine dependence
• Used cocaine for at least one day per 2-week period in the month prior to study entry
• Meets DSM-IV criteria for current major depression or dysthymia syndrome
• Scores greater than 12 on the Baseline 21 Hamilton Depression Scale
• Ages 18-60

You may not qualify if:

• Meets DSM-IV criteria for past mania (e.g., bipolar disorder), schizophrenia, or any psychotic disorder other than transient psychosis due to drug abuse
• Scores less than 11 on the Baseline 21 Hamilton Depression Scale
• History of seizures
• History of an allergic reaction to mirtazapine
• Chronic organic mental disorder
• Current suicidal risks or any history of suicidal behavior
• Pregnant, breastfeeding, or unwilling to use an adequate method of contraception for the duration of the study
• Unstable physical disorders, including high blood pressure, acute hepatitis, or diabetes
• Coronary vascular disease as indicated by history, or suspected by abnormal electrocardiogram, or history of cardiac symptoms
• Cardiac conduction system disease, as indicated by an electrocardiogram QRS duration greater than 0.11
• History of failure to respond to a previous trial of mirtazapine
• Currently taking psychotropic medication
• Meets DSM-IV criteria for opioid or sedative-hypnotic dependence
• Meets DSM-IV criteria for alcohol dependence with evidence of clinically significant physiological dependence in need of medically supervised detoxification
• Current alcohol or marijuana dependence identified as the main problem for seeking treatment; individuals with alcohol or marijuana dependence (without significant physiological dependence) and cocaine dependence are eligible, as long as cocaine is identified as the primary substance problem for which they are seeking treatment

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Research Foundation for Mental Hygiene, Inc.

New York, New York, 10032, United States

Location

Related Links

• service website

MeSH Terms

Conditions

Cocaine-Related Disorders; Depression

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Early cocaine responders were the most likely to achieve three weeks of continuous abstinence. 20% of patients on mirtazapine did not have any detectable blood level, therefore, poor compliance may have prevented detection of a medication effect.

Results Point of Contact

• Title: Dr Wilfrid Raby
• Organization: Columbia University

rabywil@nyspi.columbia.edu

212-923-3031

Study Officials

• Wilfrid Raby, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2005
• First Posted: November 7, 2005
• Study Start: May 1, 2006
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 25, 2017
• Results First Posted: October 25, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)