Marijuana DependenceNCT00598052
Treatment of Marijuana Withdrawal Syndrome Using Escitalopram and Cognitive-Behavior Therapy
A study testing Escitalopram in people with Marijuana Dependence, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Marijuana Dependence
- What is being tested?
- Escitalopram
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2007to Oct 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 20-45
- DSM IV criteria of marijuana dependence.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sourasky Medical Center
Tel Aviv, 64239
Irit Ben-Avi, Ph.D, 97236973685, iritbe@gmail.com
Eti Tal, B.A, 97236973685, etital10@walla.com
About this study
Official title: Treatment of Marijuana Withdrawal Syndrome Using Escitalopram and Cognitive-Behavior Therapy- a Double-Blind Placebo-Controlled Study
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.
Read the 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.
- Conditions
- Marijuana Dependence
- Being tested
- Escitalopram
- Keywords
- Marijuana dependence withdrawal Escitalopram
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Cipralex
10mg/day
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Escitalopram + cognitive-behavior treatment Receives: Drug: Escitalopram |
| B | Placebo comparator | Placebo + cognitive-behavior therapy Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clean urine THC samples
Measured: Every 2 weeks
Secondary outcomes (1)
Questionnaire ratings of anxiety and depression and withdrawal symptoms
Measured: Every week of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionOct 2008 (estimated)
- Study completionOct 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marijuana DependenceStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Miki Bloch, M.D, Principal investigator, Sourasky Medical center, Tel AvivAviv M Weinstein, Ph.D, Principal investigator, Sourasky Medical Center Tel Aviv, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598052
- Sponsor's protocol ID
- TASMC-7.1.08-CTIL
- Other IDs
- Sponsored by IADA
- Status last verified
- Jan 2008
- First submitted
- 9 Jan 2008
- Last updated
- 1 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Marijuana Withdrawal Syndrome Using Escitalopram and Cognitive-Behavior Therapy- a Double-Blind Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT00598052
- Acronym / sponsor ID
- TASMC-7.1.08-CTIL
- Conditions
- Marijuana Dependence
- Keywords
- Marijuana dependence withdrawal Escitalopram
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Dec 2007
- Primary completion
- Oct 2008 (estimated)
- Study completion
- Oct 2008 (estimated)
- First posted
- 18 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: EscitalopramEscitalopram + cognitive-behavior treatment |
| B | Placebo comparator | Drug: EscitalopramPlacebo + cognitive-behavior therapy |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men and women aged 20-45
- DSM IV criteria of marijuana dependence.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EscitalopramAlso: Cipralex10mg/day | Drug | A, B |
Primary outcome
Clean urine THC samples
Time frame: Every 2 weeks
1 secondary outcome
Questionnaire ratings of anxiety and depression and withdrawal symptoms
Time frame: Every week of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miki Bloch, M.D principal investigator
Sourasky Medical center, Tel Aviv
Aviv M Weinstein, Ph.D principal investigator
Sourasky Medical Center Tel Aviv, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Escitalopram in people with Marijuana Dependence, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aviv M Weinstein, Ph.D (97236973685, avivmw@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clean urine THC samples (time frame: Every 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2008.