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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01510015
First received: December 27, 2011
Last updated: January 10, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Cannabis Dependence
Psychostimulant Dependence
Drug: Risperidone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of Psychological and Pharmacological Treatment of Psycho-stimulant and Cannabis-dependent Users in Kfar Izun in Israel

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Questionnaire ratings of anxiety, depression and psychotic symptoms [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: At baseline and after 4 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Individual and group therapy
Active Comparator: Counseling
Participants will receive individual and group therapy
Drug: Risperidone
variable dose
Other Name: Individual and group therapy

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.

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510015

Contacts
Contact: Aviv M Weinstein, Ph.D +97236973536 avivweinstein@yahoo.com
Contact: Hedva Shaham, M.D +97236973536 hedval@gmail.com

Locations
Israel
Sourasky Medical center Not yet recruiting
Tel Aviv, Israel, 64239
Principal Investigator: Aviv Weinstein, Ph.D         
Principal Investigator: Einat Even-Sapir, MD Ph.D         
Sub-Investigator: Hedva Lerman-Shaham, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Study Director: Michal Roll, Ph.D Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Michal Roll PhD,MBA, Head of Research and Development, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01510015     History of Changes
Other Study ID Numbers: 0503-11-TLV
Study First Received: December 27, 2011
Last Updated: January 10, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
cannabis
psychostimulants
psychosis

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Mental Disorders
Central Nervous System Stimulants
Risperidone
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 26, 2014