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

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Psychostimulant Dependence; Cannabis Dependence

Treatments: Drug: Risperidone

Study type: Interventional

Funder types: Other

Identifiers

NCT01510015

0503-11-TLV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 21 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Anti-psychotic medication

Active Comparator group

Description:

Participants are treated with psychological treatment both group and individually as well as medications according to their mental condition.

Treatment:

Drug: Risperidone

Counseling

Active Comparator group

Description:

Participants will receive individual and group therapy

Treatment:

Drug: Risperidone