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A Free Treatment Study for Cocaine Dependence Looking at the Effectiveness of Mirtazapine in Treating Cocaine Dependent Individuals Who Also Suffer From Depression
This study is currently recruiting participants.
Verified October 2011 by New York State Psychiatric Institute

First Received on November 3, 2005.   Last Updated on October 17, 2011   History of Changes
Sponsor: New York State Psychiatric Institute
Collaborator: National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party): Herbert D. Kleber, M.D., National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00249444
  Purpose

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.


Condition Intervention Phase
Cocaine Dependence
Depression
Drug: Mirtazapine
Drug: Placebo
Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo Controlled Trial of Mirtazapine for Patients With Depression and Cocaine Dependence

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Cocaine use measured by self reported use [ Time Frame: measured daily by self report for 8 weeks of the trial or length of study participation ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: May 2006
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Mirtazapine
Drug: Mirtazapine
Mirtazapine
Other Name: Remeron
Placebo Comparator: 2
placebo
Drug: Placebo
placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00249444

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

Locations
United States, New York
Research Foundation for Mental Hygiene, Inc. Recruiting
New York, New York, United States, 10032
Contact: Lisa Sanfilippo, BA     212-740-3207     sanfili@pi.cpmc.columbia.edu    
Principal Investigator: Wilfrid Raby, M.D.            
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Herbert Kleber, MD New York State Psychiatric Institute
  More Information

No publications provided

Responsible Party: Herbert D. Kleber, M.D., Professor of Psychiatry Director, Division on Substance, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00249444     History of Changes
Other Study ID Numbers: NIDA-09236-13, P50DA009236, P50DA009236-13, DPMC
Study First Received: November 3, 2005
Last Updated: October 17, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Depression
Depressive Disorder
Cocaine-Related Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Substance-Related Disorders
Cocaine
Mirtazapine
Mianserin
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Histamine H1 Antagonists

ClinicalTrials.gov processed this record on February 09, 2012