Evaluation of the Effects of Treatment of Psycho-stimulant and Cannabis-dependent Users in Israel

Not Applicable

• Conditions: Cannabis Dependence; Psychostimulant Dependence
• Interventions: Drug: Risperidone

• Registration Number: NCT01510015
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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.

Study Timeline

• Study First Submitted: 2011-12-27
• Status Verified: 2012-01
• Study Start: 2012-01
• Study First Submitted QC: 2012-01-10
• Last Update Submitted: 2012-01-10
• Study First Posted: 2012-01-13
• Last Update Posted: 2012-01-13
• Primary Completion: 2013-10
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• cannabis dependence with or without history of psychosis.

Exclusion Criteria

• pregnant women
• under 18
• neurological damage
• HIV positive
• dependence on other drugs such as heroin
• cocaine or alcohol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anti-psychotic medication	Risperidone	Participants are treated with psychological treatment both group and individually as well as medications according to their mental condition.
Counseling	Risperidone	Participants will receive individual and group therapy

Primary Outcome Measures

Name	Time	Method
Questionnaire ratings of anxiety, depression and psychotic symptoms	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 Outcome Measures

Name	Time	Method
Dopamaine receptor D2 occupancy	At baseline and after 4 months	Measures of dopamine receptor D2 occupancy using \[I123\] IBZM in Single Photon Emitted Tomography (IBZM) will be taken before and after treatment at 4 months.

Trial Locations

Locations (1)

Sourasky Medical center; 🇮🇱 Tel Aviv, Israel