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The efficacy of buprenorphine augmentation in treatment of psychosis

Clinical trial to evaluate the efficacy of buprenorphine augmentation in treatment of psychosis in opium addicted bipolar patients with psychotic feature

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016040527236N1
Enrollment
60
Registered
2017-10-31
Start date
2016-09-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BMD type 1. Mania with psychotic symptoms

Interventions

Intervention 1: Buprenorphine, 2 mg Tab, 4-6 mg for 1st day, 6-8 mg daily for 2 weeks. Intervention 2: Buprenorphine plasebo.
Treatment - Drugs
Buprenorphine, 2 mg Tab, 4-6 mg for 1st day, 6-8 mg daily for 2 weeks
Buprenorphine plasebo

Sponsors

Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age 18-65; Diagnosis of BMD type I; The initial severity of positive symptoms; Opioid abuse for 6 months before admission. Exclusion criteria: A history of methamphetamine use within 3 months; Dependence on alcohol, benzodiazepines or hallucinogens; Diagnosis of methamphetamine-induced stable psychosis ; Taking antipsychotics or mood stabilizers two weeks before admission; MR; Head damage that cause or worsen mood or psychotic features in patient; Major cognitive impairment; Development of delirium during the study 9- Disabling medical disorder 10- Consumption of opioid agonists such as buprenorphine or others two weeks before hospitalization 11- Non persian language 12- A history of coronary artery disease 13- Changes in the ECG because of angina during treatment

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Changes in psychotic symptoms. Timepoint: Week 1, week 2. Method of measurement: BPRS questionnaire.;Symptoms of opiate withdrawal. Timepoint: Week 1, week 2. Method of measurement: COWS questionnaire.;Illness severity. Timepoint: Week 1, week 2. Method of measurement: CGI questionnaire.

Secondary

MeasureTime frame
The severity of depression. Timepoint: Week 1, week 2. Method of measurement: MARDS questionnaire.;The severity of mania. Timepoint: Week 1, week 2. Method of measurement: YMRS questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mehdi Alimardanzadeh

Shahid Beheshti hospital

dr.alimardanzadeh@gmail.com+98 34 3211 1006

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026