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View Clinical Trial (Medical Research Study)
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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 - NCT00249444-10032 (Clinical Trial 132964)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy132964.aspx
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| City: |
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New York |
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State:
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NY |
| Zip Code: |
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10032 |
| Conditions: |
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Cocaine Dependence - Depression |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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Research Foundation for Mental Hygiene, Inc.
New York, NY 10032
United States
Primary Contact:
Lisa Sanfilippo, BA
Email: sanfili@pi.cpmc.columbia.edu
Phone: 212-740-3207
Secondary Contact:
Lisa Sanfilippo, BA
Email: sanfili@pi.cpmc.columbia.edu
Phone: 212-740-3207 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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