Examination of Cognitive Function in Patients Treated With Subutex

Opiate Addiction Clinical Trial

Official title:

Examination of Cognitive Function, Weight, Sexual Function in Patients Receiving Treatment With Subutex at 3 Months Without Using Opiates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00687089
• Other study ID #: Subutex-214CTIL
• Status: Completed
• Phase: N/A
• First received: May 27, 2008
• Last updated: January 25, 2009
• Start date: June 2008
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: BeerYaakov Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

People who addicted to Heroin and other opiates suffer from a disease with approved genetic basis. It causes to a behavioral response as searching and using those drugs even though they know it causes severe damages as physiological, familiar and legal affairs.

The popular treatment's goal is to "clean" the people from any drug. In a medical and pharmacological point of view there is no sense in this approach for all people. This point of view believes that Buprenorphine (Subutex) is a correct pharmacological treatment.

The hypothesis of this research is that people using Buprenorphine have difficulties in gaining weight, in sexual and cognitive function (according to subjects' reports)

Description:

People who addicted to Heroin and other opiates suffer from a disease with approved genetic basis. It causes to a behavioral response as searching and using those drugs even though they know it causes severe damages as physiological, familiar and legal affairs.

The popular treatment's goal is to "clean" the people from any drug. In a medical and pharmacological point of view there is no sense in this approach for all people. This point of view believes that Buprenorphine (Subutex) is a correct pharmacological treatment.

The hypothesis of this research is that people using Buprenorphine have difficulties in gaining weight, in sexual and cognitive function (according to subjects' reports) We examine people who stopped opiates and began Buprenorphine. Every participant in the study will have two visits: the first one before receiving Buprenorphine and the second one after 3 months of receiving Buprenorphine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• People who suffer from addiction problems (opiates)

• People who willing to to start Buprenorphine treatment

• People who willing to cooperate with study tests and questionnaires

• People aged 18 to 70

Exclusion Criteria:

• People who suffer from any neurocognitive problems

• People who suffer from mental illnesses

• People who are having legal guardian

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Opiate Addiction

Intervention

Other:
• Sexual, cognitive functional tests and measurement weight

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
BeerYaakov Mental Health Center	Ebetim Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ASI quationarry, neurocognitive computerized tests, MMSE test, Sexual function questionnaire and satisfaction questionnaire		In 2 visits during the study	No

External Links

•   "Ebetim" clinic where the study will be conducted