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Examination of Cognitive Function in Patients Treated With Subutex

This study has been completed.
Sponsor:
Collaborator:
Ebetim Clinic
Information provided by:
BeerYaakov Mental Health Center
ClinicalTrials.gov Identifier:
NCT00687089
First received: May 27, 2008
Last updated: January 25, 2009
Last verified: January 2009
  Purpose

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)


Condition Intervention
Opiate Addiction
Other: Sexual, cognitive functional tests and measurement weight

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Examination of Cognitive Function, Weight, Sexual Function in Patients Receiving Treatment With Subutex at 3 Months Without Using Opiates

Resource links provided by NLM:


Further study details as provided by BeerYaakov Mental Health Center:

Primary Outcome Measures:
  • ASI quationarry, neurocognitive computerized tests, MMSE test, Sexual function questionnaire and satisfaction questionnaire [ Time Frame: In 2 visits during the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subutex group
People who used opiates and willing to start with subutex treatment
Other: Sexual, cognitive functional tests and measurement weight

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

People who suffer from addiction problems (opiates) and willing to start Buprenorphine treatment

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: Aviva Wolf, "Hebetim" psychiatric and psychologic clinic- private clinic
ClinicalTrials.gov Identifier: NCT00687089     History of Changes
Other Study ID Numbers: Subutex-214CTIL
Study First Received: May 27, 2008
Last Updated: January 25, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by BeerYaakov Mental Health Center:
Opiates
Subutex
Buprenorphine
Patients who addicted to opiates

Additional relevant MeSH terms:
Buprenorphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014