Official Title: “A Placebo Controlled Trial of Mirtazapine for Patients With Depression and Cocaine Dependence”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2011

Cocaine abuse and depression often occur together. Individuals suffering from both are usually not able to quit abusing cocaine. Past research conducted on alcohol dependent individuals also suffering from depression showed that these individuals were able to successfully quit drinking with the addition of an antidepressant medication. Mirtazapine is a medication currently used to treat depression. This study will evaluate the efficacy of mirtazapine, used in combination with behavioral therapy, in treating cocaine dependent individuals who also suffer from depression.

Participants in this 8-week trial will be randomly assigned to receive either mirtazapine or placebo. Prior to starting medication treatment, participants will undergo an initial 2-week phase consisting of psychosocial and behavioral therapy. The purpose of this lead-in phase is to achieve initial reduction or abstinence in cocaine use, while observing cocaine withdrawal symptoms and mood changes associated with depression. During these first 2 weeks, participants will attend three study visits each week, at which time they will participate in motivational interviews and cognitive behavioral relapse prevention therapy. During this phase, participants who successfully remain abstinent from cocaine use will be rewarded with high-value monetary vouchers.

Upon completing the lead-in phase, participants will be randomly assigned to receive either mirtazapine or placebo. Participants will attend study visits twice each week for 8 weeks.

Mood and drug use will be evaluated at each study visit. Cognitive behavioral relapse prevention therapy will continue throughout the study. In addition, participants will earn low-value monetary vouchers contingent on cocaine abstinence.

At the end of Week 8, participants will enter the lead-out phase. At this time, those participants whose mood has significantly improved will be able to continue treatment for an additional 8 weeks. Participants whose mood has not shown improvement will be tapered off their assigned medication treatment and will be offered treatment with an alternative medication. Following completion of the lead-out phase, all participants will be referred for continuing care in the community.

Intervention(s) in this Clinical Trial

• Drug: Mirtazapine
  • Mirtazapine
• Drug: Placebo
  • placebo

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Mirtazapine
• Placebo Comparator: 2
  • placebo

Primary Measures

• Reduction in cocaine use; measured throughout the study
  • Time Frame: daily
    Safety Issue?: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• History of neutropenia or agranulocytosis with fever and an infection

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Herbert Kleber, MD Principal Investigator New York State Psychiatric Institute  

Overall Contact: Lisa Sanfilippo, BA 212-740-3207 sanfili@pi.cpmc.columbia.edu

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00249444

Study ID Number: NIDA-09236-13

ClinicalTrials.gov Identifier: NCT00249444

Health Authority: United States: Federal Government