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| 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 |
| 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Lisa Sanfilippo, BA | 212-740-3207 | sanfili@pi.cpmc.columbia.edu |
| 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. | |
| Principal Investigator: | Herbert Kleber, MD | New York State Psychiatric Institute |
More Information
| 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 |
|
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 |