Evaluation of the Effects of Psychological and Pharmacological Treatment of Psycho-stimulant and Cannabis-dependent Users in Kfar Izun in Israel
Overview
- Phase
- N/A
- Intervention
- Risperidone
- Conditions
- Cannabis Dependence
- Sponsor
- Tel-Aviv Sourasky Medical Center
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Questionnaire ratings of anxiety, depression and psychotic symptoms
- Last Updated
- 14 years ago
Overview
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.
Detailed Description
There is a significant number of cannabis and psychostimulant users that experience psychotic episodes and require psychiatric treatment. 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 using \[I123\] IBZM in Single Photon Emitted Tomography (SPECT) before and after treatment 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.
Investigators
Michal Roll PhD,MBA
Head of Research and Development
Tel-Aviv Sourasky Medical Center
Eligibility Criteria
Inclusion Criteria
- •cannabis dependence with or without history of psychosis.
Exclusion Criteria
- •pregnant women
- •neurological damage
- •HIV positive
- •dependence on other drugs such as heroin
- •cocaine or alcohol
Arms & Interventions
Anti-psychotic medication
Participants are treated with psychological treatment both group and individually as well as medications according to their mental condition.
Intervention: Risperidone
Counseling
Participants will receive individual and group therapy
Intervention: Risperidone
Outcomes
Primary Outcomes
Questionnaire ratings of anxiety, depression and psychotic symptoms
Time Frame: 4 months
Questionnaire measures of anxiety (Spielberger) Depression (BDI) and psychotic symptoms (PNAAS) will be used at baseline, during treatment and follow up at 4 months
Secondary Outcomes
- Dopamaine receptor D2 occupancy(At baseline and after 4 months)