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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01510015
Enrollment
100
Registered
2012-01-13
Start date
2012-01-31
Completion date
2013-11-30
Last updated
2012-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cannabis Dependence, Psychostimulant Dependence

Keywords

cannabis, psychostimulants, psychosis

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.

Interventions

DRUGRisperidone

variable dose

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Questionnaire ratings of anxiety, depression and psychotic symptoms4 monthsQuestionnaire measures of anxiety (Spielberger) Depression (BDI) and psychotic symptoms (PNAAS) will be used at baseline, during treatment and follow up at 4 months

Secondary

MeasureTime frameDescription
Dopamaine receptor D2 occupancyAt baseline and after 4 monthsMeasures of dopamine receptor D2 occupancy using \[I123\] IBZM in Single Photon Emitted Tomography (IBZM) will be taken before and after treatment at 4 months.

Countries

Israel

Contacts

Primary ContactAviv M Weinstein, Ph.D
avivweinstein@yahoo.com+97236973536
Backup ContactHedva Shaham, M.D
hedval@gmail.com+97236973536

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026