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Lithium Cannabis Withdrawal Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00114439
First Posted: June 15, 2005
Last Update Posted: September 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The University of New South Wales
Information provided by:
Sydney South West Area Health Service
  Purpose
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.

Condition Intervention Phase
Cannabis Dependence Substance Withdrawal Syndrome Drug: Lithium carbonate Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Trial of Lithium for the Management of Cannabis Withdrawal

Resource links provided by NLM:


Further study details as provided by Sydney South West Area Health Service:

Primary Outcome Measures:
  • Severity of reported cannabis withdrawal symptoms
  • Treatment retention
  • Cannabis use
  • Depression
  • Anxiety
  • Aggression/Anger
  • Sleep difficulty

Estimated Enrollment: 25
Study Start Date: September 2005
Study Completion Date: September 2006
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114439


Locations
Australia, New South Wales
Corella Drug Treatment Service
Fairfield, New South Wales, Australia, 2176
Sponsors and Collaborators
Sydney South West Area Health Service
The University of New South Wales
Investigators
Principal Investigator: Adam R Winstock, MBBS BSc MSc MRCP(UK) MRCP Corella Drug Treatment Service
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00114439     History of Changes
Other Study ID Numbers: SSWAHS HREC 2005/047
UNSW HREC 04168
First Submitted: June 14, 2005
First Posted: June 15, 2005
Last Update Posted: September 27, 2007
Last Verified: September 2007

Keywords provided by Sydney South West Area Health Service:
cannabis withdrawal
lithium
Cannabis withdrawal syndrome

Additional relevant MeSH terms:
Marijuana Abuse
Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs