Effect of buprenorphine on the treatment of psychosis in bipolar patients with psychotic symptoms

Evaluation of the effect of buprenorphine on the treatment of psychosis in opioid-dependent bipolar patients with psychotic signs

A randomized, double-blind, placebo-controlled clinical trial will be performed on 60 patients with type I BMD who will be randomly divided into two groups of 30 each.

The study will be conducted in Shahid Beheshti Hospital in Kerman. The subjects will be randomly divided into two intervention and control groups. The intervention group will receive sublingual bupronorphine and in control group placebo will be received and psychosis signs in first and fourth days are assessed by interview

Inclusion criteria: age 18 to 65, diagnosis of type 1 BMD (Depression episode, psychotic panel mania) (based on DSM-V criteria), primary positive symptom severity: BPRS psychotic subscale with score greater than or equal to 12, and at least two items BPRS psychotic score of 4 or higher and exclusion criteria include: 3-month history of methamphetamine use, alcohol dependence or benzodiazepines or hallucinogenic substances, methamphetamine-induced sustained psychosis diagnosis , Taking antipsychotics or mood-regulating drugs within two weeks before admission

. Intervention group, sublingual buprenorphine 1-3mg daily as needed, clonazepam 1mg or 2mg daily, three gabapentin 300mg daily, clonidine 0.2mg twice or thrice daily if tolerated. The control group will receive the above medications other than the sublingual buprenorphine and will be given placebo (manufactured by the buprenorphine tablet manufacturer. They are similar in size, color, and carved on the tablet). .

The effect of sublingual bupronorphine in combination with other drugs on psychosis in patients

In this study 60 patients will be randomly divided into two treatment groups. The way to select groups is that they will be assigned to groups based on block randomization. Block size 4 is considered. So we will have six blocks containing BBAA, ABAB, BABA, AABB, ABBA, BAAB. Each block will also be randomly selected using a dice throw. For example, if dice 4 is thrown, the AABB block is considered, so the first two patients are assigned to treatment A and the next two patients to treatment B. The dice will be thrown 15 times to complete the patient assignment to the treatment groups. The treatment will also be assigned to the treatment and control groups based on the accident (coin toss)

We randomly divided the treatment groups (sublingual buprenorphine) and the control group (placebo tablets) so that patients in these groups were unaware of the treatment assignment and the treating physician of these patients was unaware of the treatment assignment in the groups.