Mirtazapine for Treating Cocaine Dependent Individuals Who Also Suffer From Depression
NCT ID: NCT00249444
Last Updated: 2017-10-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
86 participants
INTERVENTIONAL
2006-05-31
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mirtazapine
Mirtazapine will be administered on a fixed-flexible schedule, with dose titrated up to 60 mg per day or the maximum tolerated dose.
Mirtazapine
Mirtazapine
Placebo
placebo
Placebo
placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mirtazapine
Mirtazapine
Placebo
placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Drug Abuse (NIDA)
NIH
New York State Psychiatric Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wilfrid Raby, MD
Role: PRINCIPAL_INVESTIGATOR
New York State Psychiatric Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Foundation for Mental Hygiene, Inc.
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
service website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.