- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00114439
Lithium Cannabis Withdrawal Study
September 26, 2007 updated by: Sydney South West Area Health Service
An Open Label Trial of Lithium for the Management of Cannabis Withdrawal
This trial will examine the efficacy of lithium in providing symptomatic relief from the withdrawal discomfort experienced by some dependent users of cannabis on cessation of regular use.
Significant withdrawal may be a barrier to achieving abstinence in some clients and can be associated with marked disturbances in mood, sleep, hostility and aggression.
Relief from such symptoms may be important in helping some clients achieve a period of abstinence and facilitate subsequent entry into a relapse prevention program.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
There are currently no accepted pharmacotherapies for the management of cannabis withdrawal.
A recent study by Cui et al (2001) investigated the effects and mechanism of lithium on cannabinoid withdrawal in rats.
The researchers found that lithium administration prevented the development of withdrawal symptoms, and suggested that increased oxytocin secretion resulting from lithium dosing prevented the withdrawal syndrome from occurring.
Although caution should be exercised in generalising the results of an animal study, preliminary results of a small pilot study in humans are consistent with the potential utility of lithium in the management of human cannabis withdrawal (Zhang, personal communication).
Furthermore, human use of lithium is well established and the addition of a readily available drug such as lithium carbonate would be a useful clinical tool should it prove efficacious in a series of clinical trials.
Study Type
Interventional
Enrollment (Anticipated)
25
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New South Wales
-
Fairfield, New South Wales, Australia, 2176
- Corella Drug Treatment Service
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- DSM-IV diagnosis of cannabis dependence with at least a three-month history.
- Seeking treatment for primary cannabis problem
- Withdrawal identified as barrier to abstinence
Exclusion Criteria:
- Other drug dependency (excluding nicotine)
- Client is breastfeeding or pregnant.
- Client has contraindicated medical or psychiatric conditions.
- Client currently taking other medications that may interact with lithium.
- Known hypersensitivity / side effects with Lithium.
- Currently receiving Lithium from another source.
- Currently prescribed any antidepressant / mood stabilising / antipsychotic medication.
- Currently receiving opioid pharmacotherapy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Depression
|
Anxiety
|
Severity of reported cannabis withdrawal symptoms
|
Treatment retention
|
Cannabis use
|
Aggression/Anger
|
Sleep difficulty
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Adam R Winstock, MBBS BSc MSc MRCP(UK) MRCP, Corella Drug Treatment Service
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion
December 7, 2022
Study Completion (Actual)
September 1, 2006
Study Registration Dates
First Submitted
June 14, 2005
First Submitted That Met QC Criteria
June 14, 2005
First Posted (Estimate)
June 15, 2005
Study Record Updates
Last Update Posted (Estimate)
September 27, 2007
Last Update Submitted That Met QC Criteria
September 26, 2007
Last Verified
September 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Marijuana Abuse
- Substance Withdrawal Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Antimanic Agents
- Lithium Carbonate
Other Study ID Numbers
- SSWAHS HREC 2005/047
- UNSW HREC 04168
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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