Clinical trial NCT00114439: Lithium Cannabis Withdrawal Study
Official title: An Open Label Trial of Lithium for the Management of Cannabis Withdrawal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cannabis Dependence
Substance Withdrawal Syndrome
Keywords: cannabis withdrawal
lithium
Cannabis withdrawal syndrome
Lead sponsor: Sydney South West Area Health Service
Sponsor class: OTHER_GOV
Collaborators: name: The University of New South Wales
First posted: 2005-06-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Severity of reported cannabis withdrawal symptoms
measure: Treatment retention
measure: Cannabis use
measure: Depression
measure: Anxiety
measure: Aggression/Anger
measure: Sleep difficulty
Secondary outcomes:
Other outcomes:
Locations:
city: Fairfield
country: Australia
facility: Corella Drug Treatment Service
state: New South Wales
Study officials:
affiliation: Corella Drug Treatment Service
name: Adam R Winstock, MBBS BSc MSc MRCP(UK) MRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1523/JNEUROSCI.21-24-09867.2001.