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Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects

NCT00322309 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-04-20

Study results available
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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

Interventions

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

DRUG

Mirtazapine

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

Sponsors & Collaborators

  • Boston University

    lead OTHER

Principal Investigators

  • Maryam Afshar, MD · Boston University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2009-07-31
Completion
2010-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00322309 on ClinicalTrials.gov