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Completed

NCT Number: NCT00114439

Lithium Cannabis Withdrawal Study

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.

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Key information

Conditions

Cannabis Dependence Chemically-Induced Disorders Marijuana Abuse Mental Disorders Substance Withdrawal Syndrome Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Corella Drug Treatment Service

Fairfield, New South Wales, 2176, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lithium Carbonate

Drug

Primary outcomes

  1. Severity of reported cannabis withdrawal symptoms

  2. Treatment retention

  3. Cannabis use

  4. Depression

  5. Anxiety

  6. Aggression/Anger

  7. Sleep difficulty

Sponsors and collaborators

Lead sponsor

Sydney South West Area Health Service

Other Gov

Collaborators

  • The University of New South Wales

Registry information

Official study title

An Open Label Trial of Lithium for the Management of Cannabis Withdrawal

Important dates

Study start
2005
Study completion
2006
First posted
Jun 15, 2005
Registry last updated
Sep 27, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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