Opiate AddictionNCT00687089
Examination of Cognitive Function in Patients Treated With Subutex
An observational study of Opiate Addiction, run by BeerYaakov Mental Health Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Opiate Addiction
- What is being tested?
- Sexual, cognitive functional tests and measurement weight
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People who suffer from addiction problems (opiates) and willing to start Buprenorphine treatment
Who may be able to join
- 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
Who cannot join
- People who suffer from any neurocognitive problems
- People who suffer from mental illnesses
- People who are having legal guardian
About this study
Official title: Examination of Cognitive Function, Weight, Sexual Function in Patients Receiving Treatment With Subutex at 3 Months Without Using Opiates
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)
Read the 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.
- Conditions
- Opiate Addiction
- Being tested
- Sexual, cognitive functional tests and measurement weight
- Keywords
- Opiates, Subutex, Buprenorphine, Patients who addicted to opiates
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual, cognitive functional tests and measurement weightOther
| Study group | Role | What they receive |
|---|---|---|
| Subutex group | People who used opiates and willing to start with subutex treatment Receives: Other: Sexual, cognitive functional tests and measurement weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASI quationarry, neurocognitive computerized tests, MMSE test, Sexual function questionnaire and satisfaction questionnaire
Measured: In 2 visits during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeerYaakov Mental Health Center
- Sponsor type
- Other government
- Collaborators
- Ebetim Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687089
- Sponsor's protocol ID
- Subutex-214CTIL
- Status last verified
- Jan 2009
- First submitted
- 27 May 2008
- Last updated
- 27 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Cognitive Function, Weight, Sexual Function in Patients Receiving Treatment With Subutex at 3 Months Without Using Opiates
- ClinicalTrials.gov ID
- NCT00687089
- Acronym / sponsor ID
- Subutex-214CTIL
- Conditions
- Opiate Addiction
- Keywords
- Opiates, Subutex, Buprenorphine, Patients who addicted to opiates
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- BeerYaakov Mental Health CenterOther government
- Collaborators
- Ebetim Clinic
- Study start
- Jun 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 30 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subutex group | – | Other: Sexual, cognitive functional tests and measurement weightPeople who used opiates and willing to start with subutex treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People who suffer from addiction problems (opiates) and willing to start Buprenorphine treatment
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- People who suffer from any neurocognitive problems
- People who suffer from mental illnesses
- People who are having legal guardian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sexual, cognitive functional tests and measurement weight | Other | Subutex group |
Primary outcome
ASI quationarry, neurocognitive computerized tests, MMSE test, Sexual function questionnaire and satisfaction questionnaire
Time frame: In 2 visits during the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2009.
- "Ebetim" clinic where the study will be conductedLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Opiate Addiction, run by BeerYaakov Mental Health Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASI quationarry, neurocognitive computerized tests, MMSE test, Sexual function questionnaire and satisfaction questionnaire (time frame: In 2 visits during the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2009.