Clinical Studies on the Therapeutic Effects of Mirtazapine on Drug-craving in Cocaine Addicts.
Condition: Drug-withdrawal.; Drug Abuse; Drug-induced Depressive State; AOD Craving; AODR Depressive State
MeSH terms: Substance-Related Disorders; Substance Withdrawal Syndrome; Depression
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Evaluation. Evaluation of cocaine craving was assessed weekly through the Cocaine Craving
      Questionnaire (CCQ-G) (43-46). The CCQ-G measures the desire or urge level for drug
      consumption throughout the 45 Likert items established in the Questionnaire. The Likert scale
      consisted of seven options ranging from 1 to 7. Indicating from the lowest number (1)
      complete disagree of questions asked/item and the highest number (7) complete agreement of
      questions answered/item. CCQ-G items were written in past tense, with the intention that
      participants could report their cocaine craving status (level) during the previous week. Main
      items in the CCQ-G used to assess cocaine craving defined as factors were; a). Elements that
      denote intense cocaine craving (factor 1); b). Items that related to the anticipation of
      positive results (factor 2); c). Anticipation of relief from drug-withdrawal symptoms (factor
      3); and d). Items that perceived a lack of control over cocaine consumption, denoting the
      intention and planning for cocaine consumption (factor 4).

      Each week patient were assessed about their psychopathological status through the Symptom
      Check List 90 (SCL-90-R) (47-50). The SCL-90 evaluate the psychological degree of "distress"
      shown by a subject through 90 Likert-type reagents, ranging from 0 up to 4, and grouped into
      nine dimensions, which include, somatization, obsessive-compulsive, interpersonal
      sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and
      psychoticism.

      Statistical Analysis.

      Data were expressed, as mean ± SEM. To determinate the differences in score between groups
      over time, the data were then analyzed by a two-way repeated measures ANOVA with time (week)
      as the repeated measure. If there was a significant interaction between time and treatment,
      we then performed a Tukey's post-hoc test to detect significant differences between each one
      of the factors at each experimental phase. Comparisons between mean score obtained during
      each phase were analyzed by a two-way ANOVA (treatment x phase) followed by Tukey's test for
      post-hoc comparisons. The level of statistical significance was set at p < 0.05.
    

Intervention name(s): Mirtazapine (REMERON, Schering-Plough-Organon)
Intervention type(s): Drug
Intervention description(s): During the first and second phase of the study,the mirtazapine group received 30 mg of mirtazapine daily. During the third phase, the mirtazapine group received 15 mg of mirtazapine.
Other intervention name(s): MIR
Intervention MeSH terms: Mirtazapine
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Mirtazapine.; Addiction.; Cocaine.; Cocaine-craving.; Cocaine-withdrawal