Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects

April 18, 2017 updated by: Boston University

The Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects

This research study is being done to look at the safety of the medication Mirtazapine (Remeron) in people who have cocaine dependence and depression. Hypotheses I. Cocaine usage will be less in the mirtazapine treatment group (MG) than in the control group (CG). II. A greater increase in Clinician Global Impression (CGI) score will be observed in the MG than in the CG. Secondary Hypotheses: I. A greater decrease in Hamilton Rating Scale for Depression (HAM-D) and Hamilton Rating Scale for Anxiety (HAM-A) scores will be observed in the MG than in the CG. II. A greater decrease in HIV risk behaviors will be observed in the MG than in the CG. III. A greater improvement in sleep structure will be observed in the MG than in the CG. IV. The proportion of subjects experiencing severe adverse drug reactions that necessitate termination from the study by one of the study clinicians will not differ between the MG and CG. V. Retention will be greater in MG than in CG.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cocaine dependence is a significant public health problem associated with serious medical, psychiatric, social and economic consequences. It is generally accepted that the euphoria associated with cocaine use is a result of its action on reward pathways via antagonist properties at the dopamine transporter site; cocaine also inhibits reuptake of serotonin and norepinephrine. These actions are thought to underlie cocaine's potent reinforcing properties. With prolonged use, cocaine may deplete these neurotransmitters, affect postsynaptic receptor density, and elicit an overall dysregulation of these neurotransmitter systems. These longer term consequences may account for the post-cocaine depressive symptoms often claimed by cocaine users to contribute to relapse. Treatment for cocaine dependence at the present is primarily psychosocial/behavioral. Currently there is no pharmacological agent approved for treatment of cocaine dependence in conjunction with psychosocial interventions. Several drugs currently approved for other indications are presently under consideration for treatment of cocaine dependence based on their known mechanisms and sites of action. Current approaches include strategies to (1) block the effects of cocaine, (2) substitutes for cocaine, (3) reduce craving or enhance the addict's ability to manage his/her response to craving, and (4) treat underlying conditions (or consequences of cocaine use) that may predispose toward dependence.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnostic Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of cocaine dependence.
  • HAM-D score of 12 or above and history of autonomous depression, defined as meeting DSM-IV criteria for major depression or dysthymic disorder during any lifetime period of abstinence of 30 days or longer.
  • At least one urine toxicology positive for cocaine benzoylecgonine (BE) over the consecutive two-week baseline screening period during which 6 urine samples have been obtained
  • Males and non-pregnant, non-nursing females, 18-64 years of age (inclusive).
  • Individuals able to give written informed consent and willing to comply with all study procedures.

Exclusion Criteria:

  • Any Axis I diagnosis that, in the opinion of the Principal Investigator, may interfere with the course of the trial.
  • Physiological dependence on alcohol or opiates requiring medical detoxification.
  • A medical or neurological illness that in the clinical judgment of the investigator would make study compliance difficult or contraindicate the use of mirtazapine.
  • Any clinically significant abnormal lab values or liver function tests (LFTs) which are greater than 3 times the normal limit.
  • The need or intention to use concurrently with or within four weeks prior to study drug administration, any of the following medications: monoamine oxidase inhibitors and/or sibutramine. In addition, other medications such as alpha2-agonists and medications which affect the enzymes Cytochrome P450 1A2 (CYP1A2), Cytochrome P450 2D6 (CYP2D6), Cytochrome P450 3A4 (CYP3A4) (as inhibitors, substrates, or inducers), and serotonin modulators should be used with caution. The research physician will decide on this issue. A listing of these substances may be found in Appendix I.
  • Females of childbearing potential who do NOT agree to use a medically acceptable method of birth control (barrier, intrauterine device (IUD), oral or depot contraceptive medication, or complete abstinence).
  • Positive pregnancy test.
  • Breastfeeding
  • Known drug allergy or sensitivity to mirtazapine.
  • Participation in an investigational drug or device study within 1 month of enrollment in the present study.
  • Enrollment in an opiate-substitution (i.e., methadone, levo acetyl methadol (LAAM)) treatment program within 45 days of enrolling in the present study.
  • Individuals having taken LAAM, methadone or naltrexone within 14 days of enrollment in the present study.
  • Individuals who, in the clinical judgment of the Investigator, are actively and acutely suicidal.
  • Subjects, who in the opinion of the investigator, have a medical condition that may interfere with study assessments and/or put them at undue risk.
  • Subjects, who in the opinion of the investigator, will have difficulty complying with study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mirtazapine

Mirtazapine administration as follows:

Days 1-4 15mg of mirtazapine daily Days 5-9 30mg of mirtazapine daily Days 10-78 45mg of mirtazapine daily Days 79-81 30mg of mirtazapine daily Days 82-84 15mg of mirtazapine daily
Drug: Mirtazapine
Days 1-4 15mg Days 5-9 30 mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg
Other Names:
  • Remeron
Placebo Comparator: Placebo- Sugar pill
Matched Placebo given daily days 1-84
Other: Placebo
Placebo for days 1-4 Placebo for days 5-9 Placebo for days10-78 Placebo for days 79-81 Placebo for days 82-84

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Ln Benzoylecgonine Concentration
Time Frame: Week 11
Week 11

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Clinical Global Impression Observer (CGI-O)Comparison for Week 11
Time Frame: Week 11
Clinician's overall assessment of the subjects global functioning including the severity of the subject's cocaine use, cocaine seeking, use of other drugs, psychiatric symptoms, medical problems, maladaptive family/social coping, and coping with issues related to employment, housing, and legal issues. Totals range between 7 (for none) to 56 for most severe.
Week 11
Hamilton Depression Rating Scale
Time Frame: Week 11
Subjects are assessed on 24 characteristics of depressive disorders. Scale scores may range from 0 for no depressive symptoms to 75.
Week 11
Pill Count
Time Frame: Weeks 1 to 11
Percentage of medication capsules administered based on the ratio of the number of capsules administered to the total number dispensed for entire period during which subjects were in treatment.
Weeks 1 to 11
Percent Urines Positive for Riboflavin
Time Frame: Weeks 1-11
This measure of adherence was determined by finding the percent of total urines examined that were positive for riboflavin, which had been added to each medication tablet.
Weeks 1-11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maryam Afshar, MD, Boston University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2006

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-22530

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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