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Investigation on efficacy of Buprenorphine Maintenance Treatment (BMT) for Methamphetamine dependants; a before - after phase II clinical trial

Protocol summary

Summary
Methamphetamine dependency is one of the serious social concerns in Iran and unfortunately there are no drug of choice for this dependency. The aim of this study is Investigation on efficacy of buprenorphine maintenance treatment (BMT) for methamphetamine dependents as a before - after phase II clinical trial on 21 patients in Qazvin. Inclusion criteria are ability to reading and writing and age between 18 and 55. Exclusion criteria are all of contraindications of buprenorphine and no agreement to participation in study. Firstly, participants will be monitored in one week running period for medical and psychiatric assessments and if they need antipsychotic medications, olanzapine with the minimum dose of 5 mg and maximum dose of 15 mg will be prescribed and also they will fill Leeds dependency questionnaire (LDQ), Obsessive Compulsive Drug Use Scale (OCDUS) questionnaire, lite version of Addiction Severity Index (ASI – Lite) questionnaire, WHO Quality of Life-BREF (WHOQOL-BREF) questionnaire and also Cognitive Abilities Questionnaire (CAQ). In this period, blood sample will be given for LFT study. After running period, participants will be entered in intervention period and they will be visited three times a week and urine rapid tests for methamphetamine, morphine and benzodiazepines will be checked. In addition to receiving buprenorphine in every visits, psychotherapy sessions will be held weekly. LDQ, OCDUS, WHOQOL-BREF and (CAQ) will be filled in 4th, 8th and 12th week again and ASI – Lite questionnaire will be held on 12th week again. After 12 weeks, all participants will be followed for 12 weeks as a follow up period. CAQ will be filled at the end of 24th weeks at the end of follow up period.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013112315499N1
Registration date: 2014-07-16, 1393/04/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-07-16, 1393/04/25
Registrant information
Name
Schwann Shariatirad
Name of organization / entity
Student Research Center of International Campus, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5574 5975
Email address
shariatirad@gmail.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation on efficacy of Buprenorphine Maintenance Treatment (BMT) for Methamphetamine dependants; a before - after phase II clinical trial
Public title
Efficacy of Buprenorphine in the Methamphetamine Dependency
Purpose
Treatment
Inclusion/Exclusion criteria
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;
Age
From 18 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 21
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
6th floor, central building of university, Qods st, Keshavarz blv
City
Tehran
Postal code
Approval date
2014-05-25, 1393/03/04
Ethics committee reference number
130/322/ص/93

Health conditions studied

1

Description of health condition studied
Methamphetamine dependency
ICD-10 code
F15
ICD-10 code description
Mental and behavioural disorders due to use of other stimulants, including caffeine

Primary outcomes

1

Description
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)

Secondary outcomes

1

Description
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

2

Description
remaining until end of study
Timepoint
after the end of the study
Method of measurement
observation of attending patient at the end of study

3

Description
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

4

Description
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

5

Description
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

6

Description
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

Intervention groups

1

Description
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.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sayeh Addiction Treatment Center
Full name of responsible person
Street address
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Yunesian
Street address
6th floor, Central building of university, Qods St., Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Faranshimi Company
Full name of responsible person
Dr. Mohammadreza Tehrani-Moghadam
Street address
No 19, Parvin St, Valiasr St
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faranshimi Company
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Effatpanah
Position
Assistant professor, Department of psychiatry
Other areas of specialty/work
Street address
Taleghani St., Qods St., Enqelab Sq.
City
Tehran
Postal code
Phone
+98 21 5574 5975
Fax
Email
m.effatpanah@gmail.com; m-effatpanah@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Student Research Center of International Campus, Tehran University of Medical Sciences
Full name of responsible person
Schwann Shariatirad
Position
M.D.
Other areas of specialty/work
Street address
3rd floor, Education Building, Ziaeian Hospital, Abozar Sq, Abozar St
City
Tehran
Postal code
Phone
+98 21 5574 5975
Fax
Email
shariatirad@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Student Research Center of International Campus, Tehran University of Medical Sciences
Full name of responsible person
Schwann Shariatirad
Position
Lecturer
Other areas of specialty/work
Street address
3rd floor, Education Building, Ziaeian Hospital, Abozar Sq., Abozar St.
City
Tehran
Postal code
Phone
+98 21 5574 5975
Fax
Email
shariatirad@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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