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

Primary Purpose

Cannabis Dependence, Psychostimulant Dependence

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Risperidone

About this trial

This is an interventional treatment trial for Cannabis Dependence focused on measuring cannabis, psychostimulants, psychosis

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Sourasky Medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Anti-psychotic medication

Counseling

Arm Description

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

Participants will receive individual and group therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01510015

First Posted

December 27, 2011

Last Updated

January 10, 2012

Sponsor

Tel-Aviv Sourasky Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01510015

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

October 2013 (Anticipated)

Study Completion Date

November 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cannabis Dependence, Psychostimulant Dependence

Keywords

cannabis, psychostimulants, psychosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Anti-psychotic medication

Arm Type

Active Comparator

Arm Description

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

Arm Title

Counseling

Arm Type

Active Comparator

Arm Description

Participants will receive individual and group therapy

Intervention Type

Drug

Intervention Name(s)

Risperidone

Other Intervention Name(s)

Individual and group therapy

Intervention Description

variable dose

Primary Outcome Measure Information:

Title

Questionnaire ratings of anxiety, depression and psychotic symptoms

Description

Questionnaire measures of anxiety (Spielberger) Depression (BDI) and psychotic symptoms (PNAAS) will be used at baseline, during treatment and follow up at 4 months

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Dopamaine receptor D2 occupancy

Description

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.

Time Frame

At baseline and after 4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Aviv M Weinstein, Ph.D

Phone

+97236973536

avivweinstein@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Hedva Shaham, M.D

Phone

+97236973536

hedval@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michal Roll, Ph.D

Organizational Affiliation

Sourasky Medical Center

Official's Role

Study Director

Facility Information:

Facility Name

Sourasky Medical center

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aviv Weinstein, Ph.D

First Name & Middle Initial & Last Name & Degree

Einat Even-Sapir, MD Ph.D

First Name & Middle Initial & Last Name & Degree

Hedva Lerman-Shaham, MD

12. IPD Sharing Statement

Learn more about this trial

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

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