Lithium Cannabis Withdrawal Study

This study has been completed.
Sponsor:
Collaborator:
The University of New South Wales
Information provided by:
Sydney South West Area Health Service
ClinicalTrials.gov Identifier:
NCT00114439
First received: June 14, 2005
Last updated: September 26, 2007
Last verified: September 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 14, 2005
Last Updated: September 26, 2007
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

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

ClinicalTrials.gov processed this record on September 18, 2014