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Lithium Cannabis Withdrawal Study

Information source: Sydney South West Area Health Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cannabis Dependence; Substance Withdrawal Syndrome

Intervention: Lithium carbonate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Sydney South West Area Health Service

Official(s) and/or principal investigator(s):
Adam R Winstock, MBBS BSc MSc MRCP(UK) MRCP, Principal Investigator, Affiliation: Corella Drug Treatment Service


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.

Clinical Details

Official title: An Open Label Trial of Lithium for the Management of Cannabis Withdrawal

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Severity of reported cannabis withdrawal symptoms

Treatment retention

Cannabis use




Sleep difficulty

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.


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


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


- Currently receiving opioid pharmacotherapy.

Locations and Contacts

Corella Drug Treatment Service, Fairfield, New South Wales 2176, Australia
Additional Information

Related publications:

Cui SS, Bowen RC, Gu GB, Hannesson DK, Yu PH, Zhang X. Prevention of cannabinoid withdrawal syndrome by lithium: involvement of oxytocinergic neuronal activation. J Neurosci. 2001 Dec 15;21(24):9867-76.

Starting date: September 2005
Last updated: September 26, 2007

Page last updated: August 23, 2015

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