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IRCT2013112315499N1 IRCT 2014-07-16 Vice chancellor for research, Tehran University of Medical Sciences Efficacy of Buprenorphine in the Methamphetamine Dependency Investigation on efficacy of Buprenorphine Maintenance Treatment (BMT) for Methamphetamine dependants; a before - after phase II clinical trial 2014-05-22 anticipated 21 Complete https://irct.ir/trial/14753 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Methamphetamine dependency. Buprenorphine 2 mg sublingual as a one tablet daily will be used in this study. This study have not control group and the dosage of the buprenorphine will be assessed in which dosage could control the methamphetamine craving..
public Mohammad Effatpanah
Taleghani St., Qods St., Enqelab Sq.
Tehran Iran (Islamic Republic of) +98 21 5574 5975 m.effatpanah@gmail.com; m-effatpanah@tums.ac.ir Tehran University of Medical Sciences scientific Schwann Shariatirad
3rd floor, Education Building, Ziaeian Hospital, Abozar Sq, Abozar St
Tehran Iran (Islamic Republic of) +98 21 5574 5975 shariatirad@gmail.com Student Research Center of International Campus, Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 1. Ability to reading and writing in Persian; 2. Age between 18 and 55 years old; 3. All participants with diagnosis of methamphetamine dependency according to the DSM IV criteria; 4. Agreement to participating in study; Exclusion criteria: 1. Participants currently enrolled in another investigational device or drug trial or previously enrolled (within last 30 days) in investigative research of a device or pharmaceutical agent; 2. Co - use of methamphetamine and methadone; 3. Inability to tolerate buprenorphine; 4. Presence of any liver failure such as hepatitis; 5. History of any lung disease; 6. Presence of any thyroid disease such hypothyroidism or hyperthyroidism; 7. Presence of adrenal gland disease such as addison disease; 8. Presence of kidney failure such as CRF, ARF, etc. 9. Presence of heart failure; 10. Presence of prostatic hyperplasia or urethra tightness; 11. History of epilepsy or uncontrolled seizures; 12. Presence of any cancer; 13. Pregnancy; 14. Any evidences to confirm participants sail buprenorphine outside the addiction treatment center or any evidences to confirm participants will not use buprenorphine; 15. No acceptance to enroll in or continue the study; 18 years 55 years Both F15 Mental and behavioural disorders due to use of other stimulants, including caffeine Treatment - Drugs Buprenorphine 2 mg sublingual as a one tablet daily will be used in this study. This study have not control group and the dosage of the buprenorphine will be assessed in which dosage could control the methamphetamine craving. Existence of methamphetamine in urine samples. Timepoint: three times in a week in first three months, one time a week in second three months of following. Method of measurement: Urine rapid test kit (Methamphetamine). Obsessive Compulsive Drug Use Scale (OCDUS) score. Timepoint: At the baseline and after that at 4th, 8th and 12th weeks after starting the intervention. Method of measurement: OCDUS questionnaire. Remaining until end of study. Timepoint: after the end of the study. Method of measurement: observation of attending patient at the end of study. Score on the Addiction Severity Index (ASI-Lite). Timepoint: At the baseline and after the end of the 12th week. Method of measurement: ASI-Lite questionnaire. Score on the Leeds Dependence Questionnaire (LDQ). Timepoint: At the baseline and after that at 4th, 8th and 12th weeks after starting the intervention. Method of measurement: LDQ questionnaire. Score on the WHO quality of life questionnaire (WHOQOL-BREF). Timepoint: At the baseline and after that at 4th, 8th and 12th weeks after starting the intervention. Method of measurement: WHOQOL-BREF questionnaire. Added at 2015-04-03: Cognitive abilities. Timepoint: Added at 2015-04-03: At the baseline and after that at 4th, 8th, 12th and 24th weeks after starting the intervention. Method of measurement: Added at 2015-04-03: Cognitive Abilities Questionnaire. Faranshimi Company Vice chancellor for research, Tehran University of Medical Sciences Faranshimi Company Approved 2014-05-25 Ethics committee of Tehran University of Medical Sciences 6th floor, central building of university, Qods st, Keshavarz blv Tehran Iran (Islamic Republic of)