The efficacy of Trimipramine in reducing the temptation and rate of relapse of methamphetamine use compared with placebo (clinical trial with a control group)

Evaluation of the effect of Trimipramine in reducing the temptation and rate of relapse of methamphetamine use compared with placebo (clinical trial with a control group)

Clinical trials with control group, parallel groups, double blind, randomized

This study is a double blind trial. The study sample population is consist of all Methamphetamine dependent referring to Farabi Hospital in Kermanshah, that 132 persons will selected in available method and randomly will be divided into two groups. In the experimental group, the participants will receive daily two pills of Trimipramine, while the control group two placebo pills daily. All subjects in all two groups will be re-evaluated by completing questionnaires at baseline, 4 weeks and at the end of the study (8 weeks after baseline), their temptation and relapse will be assessed again.

Inclusion criteria: Gender Male; Methamphetamine dependence diagnoses accordingly Diagnostic and Statistical Manual of Mental Disorders fifth edition; The dominant use of methamphetamine for at least 6 months, lack of serious psychiatric disorders and also, Patients who did not agree to participate in the study, were excluded

Intervention group: The group will receive Trimipramine treatment in two months. The daily dose will be two pills that the person will receive 75 mg in the first month and 150 mg in the second month. The control group will receive placebo treatment in two months. Daily placebo intake will be two pills. Placebo pills (lactose powder, gelatin solution, 5% and Vocel) in terms of shape, size, color and smell are similar to the Trimipramine pills.

temptation and relapse

Patients are divided into two equal groups (A and B) based on a randomized six-block table designed using Random allocation software. In order to randomly assign 132 patients to the intervention and control groups, six different blocks of 22 different letters A and B, which indicate the terminals of the trimimipermin and placebo groups, are initially created. These blocks are then numbered from one to six. In the next step, each of these blocks is randomly selected by performing 6 drawings from numbers 1 to 6 each. Thus, in each lottery, by selecting a block, a combination of 22 letters of the letters A (trimimipermin group) and B (placebo group) is obtained. At the end of the 6 drawings, after selecting 6 blocks, a total of 132 The letters A and B will be obtained. The resulting combination of letters A and B is single, and are placed in 132 separate and sealed envelopes, respectively. following each patient recourse an envelope is opened to determine the group of that patient.

The medication and placebo are delivered to the patient without sticking the label. The doctor is also unaware of the type of drug used in each group. The color and smell of main drug and placebo are the same.