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

January 10, 2012 updated by: Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Tel Aviv, Israel, 64239
        • Sourasky Medical Center
        • Principal Investigator:
          • Einat Even-Sapir, MD Ph.D
        • Principal Investigator:
          • Aviv Weinstein, Ph.D
        • Sub-Investigator:
          • Hedva Lerman-Shaham, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anti-psychotic medication
Participants are treated with psychological treatment both group and individually as well as medications according to their mental condition.
Drug: Risperidone
variable dose
Other Names:
  • Individual and group therapy
Active Comparator: Counseling
Participants will receive individual and group therapy
Drug: Risperidone
variable dose
Other Names:
  • Individual and group therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dopamaine receptor D2 occupancy
Time Frame: 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.
At baseline and after 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Study Director: Michal Roll, Ph.D, Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

December 27, 2011

First Submitted That Met QC Criteria

January 10, 2012

First Posted (Estimate)

January 13, 2012

Study Record Updates

Last Update Posted (Estimate)

January 13, 2012

Last Update Submitted That Met QC Criteria

January 10, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0503-11-TLV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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