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Mirtazapine for Treating Cocaine Dependent Individuals Who Also Suffer From Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00249444
Recruitment Status : Completed
First Posted : November 7, 2005
Results First Posted : October 25, 2017
Last Update Posted : October 25, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Depression Drug: Mirtazapine Drug: Placebo Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo Controlled Trial of Mirtazapine for Patients With Depression and Cocaine Dependence
Study Start Date : May 2006
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Mirtazapine

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Mirtazapine
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
Mirtazapine
Other Name: Remeron
Placebo Comparator: Placebo
placebo
 Drug: Placebo
placebo


Outcome Measures
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Primary Outcome Measures :
  1. Cocaine Abstinence During Last Three Weeks of Study [ Time Frame: 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

  2. Depression Score on Hamilton - Depression 25 Item [ Time Frame: End of 8 week study or last week of participation ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
  • Ages 18-60

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 (< 500 granulocytes /cc) or Agranulocytosis (<500 granulocytes/cc) with fever, infection. Concurrent intake of medications with possible neutropenic effects: chlorpromazine, carbamazepine, clozapine, chemotherapeutic drugs, immunosuppressant medications, interferons, ganciclovir, protease inhibitors.
  • Patients not able to meet attendance requirement of 4/6 visits during the lead-in period.
  • Supplemental exclusion criteria for cold pressor test (CPT): history of frostbite, open cut or sore on foot to be immersed, history of Raynaud's phenomenon.
  • Supplemental exclusion criteria for CPT: hypertension (BP less than or equal 140/90)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00249444


Locations
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United States, New York
Research Foundation for Mental Hygiene, Inc.
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Wilfrid Raby, MD New York State Psychiatric Institute
More Information
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Additional Information:

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Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00249444    
Other Study ID Numbers: 5086/6177R NIDA-09236-13
P50DA009236 ( U.S. NIH Grant/Contract )
P50DA009236-13 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Posted: November 7, 2005    Key Record Dates
Results First Posted: October 25, 2017
Last Update Posted: October 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by New York State Psychiatric Institute:
cocaine dependence
mirtazipine
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mirtazapine
Antidepressive Agents
Psychotropic Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Serotonin 5-HT3 Receptor Antagonists