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
Summary
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 symptomsTreatment retention Cannabis use Depression Anxiety Aggression/Anger 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
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
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