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

Cannabis Dependence Clinical Trial

Official title:

Evaluation of the Effects of Psychological and Pharmacological Treatment of Psycho-stimulant and Cannabis-dependent Users in Kfar Izun in Israel

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01510015
• Other study ID #: 0503-11-TLV
• Status: Not yet recruiting
• Phase: N/A
• First received: December 27, 2011
• Last updated: January 10, 2012
• Start date: January 2012
• Est. completion date: November 2013

Study information

• Verified date: January 2012
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Aviv M Weinstein, Ph.D
• Phone: +97236973536
• Email: avivweinstein[@]yahoo.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 45 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cannabis Dependence
• Marijuana Abuse
• Psychostimulant Dependence

Intervention

Drug:
• Risperidone
variable dose

Locations

Country	Name	City	State
Israel	Sourasky Medical center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Dopamaine receptor D2 occupancy	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.	At baseline and after 4 months	Yes