Evaluation of the Effects of Treatment of Psycho-stimulant and Cannabis-dependent Users in Israel
Evaluation of the Effects of Psychological and Pharmacological Treatment of Psycho-stimulant and Cannabis-dependent Users in Kfar Izun in Israel
1 other identifier
interventional
100
1 country
1
Brief Summary
This study evaluates the effects of psychological and pharmacological treatment of regular users of cannabis and psychostimulants in a treatment center (Kfar Izun) in Israel. The participants will undergo psychological evaluation before and during treatment and follow up at 4 months. Ten participants will undergo brain imaging of the dopamine receptor D2 in order to evaluate the effects of treatment on dopamine turnover in the brain. A control group of psychiatric in-patients undergoing treatment for psychiatric illness with be recruited from Geha Hospital in Israel. It is predicted that successful treatment of regular users of cannabis will be resulted in improvement in anxiety, depression and psychotic symptoms as well as in upregulation of dopamine turnover in participants that will undergo brain imaging.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedFirst Posted
Study publicly available on registry
January 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedJanuary 13, 2012
January 1, 2012
1.8 years
December 27, 2011
January 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Questionnaire ratings of anxiety, depression and psychotic symptoms
Questionnaire measures of anxiety (Spielberger) Depression (BDI) and psychotic symptoms (PNAAS) will be used at baseline, during treatment and follow up at 4 months
4 months
Secondary Outcomes (1)
Dopamaine receptor D2 occupancy
At baseline and after 4 months
Study Arms (2)
Anti-psychotic medication
ACTIVE COMPARATORParticipants are treated with psychological treatment both group and individually as well as medications according to their mental condition.
Counseling
ACTIVE COMPARATORParticipants will receive individual and group therapy
Interventions
variable dose
Eligibility Criteria
You may qualify if:
- cannabis dependence with or without history of psychosis.
You may not qualify if:
- pregnant women
- under 18
- neurological damage
- HIV positive
- dependence on other drugs such as heroin
- cocaine or alcohol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sourasky Medical center
Tel Aviv, 64239, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michal Roll, Ph.D
Sourasky Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Research and Development
Study Record Dates
First Submitted
December 27, 2011
First Posted
January 13, 2012
Study Start
January 1, 2012
Primary Completion
October 1, 2013
Study Completion
November 1, 2013
Last Updated
January 13, 2012
Record last verified: 2012-01