Clinical Studies on the Therapeutic Effects of Mirtazapine on Drug-craving in Cocaine Addicts.
Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
Participant gender:
Summary
INTRODUCTION. One of the main problems of the treatment of cocaine-dependent patients is the
high rate of relapses occurs within the first months after detoxification. In the early
withdrawal phase, patients suffer severe anxious depressive symptoms, known in the argot as
crash, which occurs in parallel with an appetite overflowed by re-experiencing the effects of
the substance, known as craving. Most of the times, these clinical symptoms act as negative
reinforcement, which can be severe enough to induce a drug-relapse that greatly hampers the
treatment.
TYPE OF STUDY randomized, double-blind, placebo-experimental. GENERAL PURPOSE To determine
the efficacy of mirtazapine for the treatment of cocaine dependence. SPECIFIC OBJECTIVES 1)
To evaluate the efficacy in the treatment of craving in individuals with cocaine dependence
disorder treated with mirtazapine during acute withdrawal phase. 2) Determine the efficacy of
reducing anxious depressive symptomatology (Crash) associated with acute withdrawal in
subjects with cocaine dependence disorder treated with mirtazapine. 3) Evaluate the
maintenance of abstinence in patients with cocaine dependence disorder treated with
mirtazapine. 4) Determine the efficacy of mirtazapine in the treatment of subjects dependent
on cocaine comorbid with major depressive disorder.
HYPOTHESIS For pharmacokinetics and pharmacodynamics mirtazapine contribute to the reduction
in the intensity of withdrawal symptoms in cocaine dependent subjects by acting on the
neurochemical circuitry involved in the reward-seeking behavior and has a prolonged effect
anticraving. METHOD The attending physician outpatient identifies the Addiction Clinic of the
National Institute of Psychiatry who meet the inclusion criteria and invite them to
participate voluntarily. If patients accept, send them to the principal investigator for the
start of the ratings. Demographics INSTRUMENTS, MINI structured interview, Anxiety and
Depression Scale Beck Scale.
Phase:
Phase 2
Details
Lead Sponsor:
Instituto Nacional de PsiquiatrÃa Dr. Ramón de la Fuente