Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects

NCT00322309 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: H-22530
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cocaine Dependence; Depression

Keywords

Cocaine; Substance Abuse

Outcome Measures

Primary Outcomes (1)

• Ln Benzoylecgonine Concentration

  Week 11

Secondary Outcomes (4)

• The Clinical Global Impression Observer (CGI-O)Comparison for Week 11

  Week 11

• Hamilton Depression Rating Scale

  Week 11

• Pill Count

  Weeks 1 to 11

• Percent Urines Positive for Riboflavin

  Weeks 1-11

Study Arms (2)

Mirtazapine

EXPERIMENTAL

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

Placebo- Sugar pill

PLACEBO COMPARATOR

Matched Placebo given daily days 1-84

Other: Placebo

Interventions

Placebo OTHER

Placebo for days 1-4 Placebo for days 5-9 Placebo for days10-78 Placebo for days 79-81 Placebo for days 82-84

Placebo- Sugar pill

Mirtazapine DRUG

Days 1-4 15mg Days 5-9 30 mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg

Also known as: Remeron

Mirtazapine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Boston University

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Depression; Substance-Related Disorders

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Maryam Afshar, MD
• Organization: BUPA CSU, Boston University School of Medicine

maryam.afshar@bmc.org

617-414-1990

Study Officials

• Maryam Afshar, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2006
• First Posted: May 5, 2006
• Study Start: September 1, 2005
• Primary Completion: July 1, 2009
• Study Completion: February 1, 2010
• Last Updated: April 20, 2017
• Results First Posted: April 20, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)