Treatment of Marijuana Withdrawal Syndrome Using Escitalo... | NCT00598052

Studies
Treatment of Marijuana Withdrawal Syndrome Using Escitalopram and Cognitive-Behavior Therapy

NCT00598052

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Apr 1, 2008Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Marijuana Dependence

Interventions

Escitalopram

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Sponsored by IADA

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Oct 2008Estimated

Completion Date

Oct 2008Estimated

First Submitted Date

Jan 9, 2008

First Submission Date that Met QC Criteria

Jan 17, 2008

First Posted Date

Jan 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2008

Last Update Posted Date

Apr 1, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Tel-Aviv Sourasky Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Recent studies have established the reliability, validity and time course of the cannabis withdrawal syndrome. This study will investigate the effects of combined treatment of Escitalopram with cognitive-behavior therapy in alleviating the symptoms of the marijuana withdrawal syndrome in regular chronic users of marijuana. We predict that combined pharmacological treatment and cognitive-behavior therapy will help patients to abstain from using using marijuana and it will alleviate their marijuana withdrawal symptoms.

Detailed Description

Recent studies have established the reliability, validity and time course of the cannabis withdrawal syndrome characterized by symptoms of anxiety, irritability, negative mood, physical symptoms and decreased appetite. This study will investigate the effects of combined treatment of Escitalopram with cognitive-behavior therapy in alleviating the symptoms of the marijuana withdrawal syndrome in regular chronic users of marijuana. 40 patients will be blindly randomized to either active or placebo escitalopram 10mg/day, for 12 weeks followed bt 12 weeks of follow-up.

Inclusion criteria include:

Men and women age 20-45
DSM-IV diagnosis of THC dependence.

Exclusion criteria include:

Dependence on other drugs or alcohol
Bipolar Disorder or Schizophrenia, Major depression, suicidal ideation psychotic symptoms or violent thoughts
Current treatment with anti-depressant medication
Neurological disease
Physical illness (hypothyroidism, severe anemia, renal failure)
Past severe effects of SSRIs.

Outcome measures include:

urine THC analysis every two weeks
questionnaires assessing addiction severity index
depression and anxiety.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator	Escitalopram + cognitive-behavior treatment	Drug: Escitalopram
B	Placebo Comparator	Placebo + cognitive-behavior therapy	Drug: Escitalopram

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Escitalopram	Drug	10mg/day	A B	Cipralex

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clean urine THC samples		Every 2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Questionnaire ratings of anxiety and depression and withdrawal symptoms		Every week of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women aged 20-45
DSM IV criteria of marijuana dependence.

Exclusion Criteria:

Other drug or alcohol dependence
Bipolar disorder, schizophrenia, major depression, suicidal ideation, psychotic symptoms or violent thoughts
Physical illness including hypothyroidism, neurological disease, severe anemia, and renal failure
Past severe side effects of SSRIs.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aviv M Weinstein, Ph.D	Contact	97236973685		avivmw@tasmc.health.gov.il
Eti Tal, B.A	Contact	97236973685		etital10@walla.com

Overall Officials

Name	Affiliation	Role
Miki Bloch, M.D	Sourasky Medical center, Tel Aviv	Principal Investigator
Aviv M Weinstein, Ph.D	Sourasky Medical Center Tel Aviv, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sourasky Medical Center	Recruiting	Tel Aviv		64239	Israel

Condition Browse Module

MeSH Terms

ID	Term
D002189	Marijuana Abuse

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000089983	Escitalopram
D003909	Dexetimide

Ancestor Terms

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572

Browse Leaves

Not provided

Browse Branches

Not provided