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Mirtazapine for Treating Cocaine Dependent Individuals Who Also Suffer From Depression

Primary Purpose

Cocaine Dependence, Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mirtazapine
Placebo
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring cocaine dependence, mirtazipine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Research Foundation for Mental Hygiene, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Mirtazapine

Placebo

Arm Description

Mirtazapine will be administered on a fixed-flexible schedule, with dose titrated up to 60 mg per day or the maximum tolerated dose.

placebo

Outcomes

Primary Outcome Measures

Cocaine Abstinence During Last Three Weeks of Study
measured daily by self report and confimed by urine toxicology for 8 weeks of the trial or length of study participation
Depression Score on Hamilton - Depression 25 Item
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.

Secondary Outcome Measures

Full Information

First Posted
November 3, 2005
Last Updated
September 25, 2017
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00249444
Brief Title
Mirtazapine for Treating Cocaine Dependent Individuals Who Also Suffer From Depression
Official Title
A Placebo Controlled Trial of Mirtazapine for Patients With Depression and Cocaine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence, Depression
Keywords
cocaine dependence, mirtazipine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirtazapine
Arm Type
Active Comparator
Arm Description
Mirtazapine will be administered on a fixed-flexible schedule, with dose titrated up to 60 mg per day or the maximum tolerated dose.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Mirtazapine
Other Intervention Name(s)
Remeron
Intervention Description
Mirtazapine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Cocaine Abstinence During Last Three Weeks of Study
Description
measured daily by self report and confimed by urine toxicology for 8 weeks of the trial or length of study participation
Time Frame
measured daily by self report and confimed by urine toxicology for 8 weeks of the trial or length of study participation
Title
Depression Score on Hamilton - Depression 25 Item
Description
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.
Time Frame
End of 8 week study or last week of participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfrid Raby, MD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Foundation for Mental Hygiene, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.stars.columbia.edu
Description
service website

Learn more about this trial

Mirtazapine for Treating Cocaine Dependent Individuals Who Also Suffer From Depression

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