Phase 2
Completed N=86
Mirtazapine for Treating Cocaine Dependent Individuals Who Also Suffer From Depression
Cocaine Dependence · Depression
Source: ClinicalTrials.gov NCT00249444 ↗
Enrolled (actual)
86
Serious AEs
2.3%
Results posted
Oct 2017
Primary outcomePrimary: Cocaine Abstinence During Last Three Weeks of Study — 5; 9 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cocaine Abstinence During Last Three Weeks of Study |
5; 9 | — |
| PRIMARY Depression Score on Hamilton - Depression 25 Item |
38; 42 | — |
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)
Data sourced from ClinicalTrials.gov (NCT00249444). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.