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

NCT ID: NCT01510015

Last Updated: 2012-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-11-30

Brief Summary

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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

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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.

Conditions

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Cannabis Dependence Psychostimulant Dependence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anti-psychotic medication

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

Group Type ACTIVE_COMPARATOR

Risperidone

Intervention Type DRUG

variable dose

Counseling

Participants will receive individual and group therapy

Group Type ACTIVE_COMPARATOR

Risperidone

Intervention Type DRUG

variable dose

Interventions

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Risperidone

variable dose

Intervention Type DRUG

Other Intervention Names

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Individual and group therapy

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Michal Roll PhD,MBA

Head of Research and Development

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michal Roll, Ph.D

Role: STUDY_DIRECTOR

Sourasky Medical Center

Locations

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Sourasky Medical center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Central Contacts

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Aviv M Weinstein, Ph.D

Role: CONTACT

+97236973536

Hedva Shaham, M.D

Role: CONTACT

+97236973536

Other Identifiers

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0503-11-TLV

Identifier Type: -

Identifier Source: org_study_id

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