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Lithium Cannabis Withdrawal Study

S

Sydney South West Area Health Service

Status and phase

Completed
Phase 2

Conditions

Cannabis Dependence
Substance Withdrawal Syndrome

Treatments

Drug: Lithium carbonate

Study type

Interventional

Funder types

Other

Identifiers

NCT00114439
SSWAHS HREC 2005/047
UNSW HREC 04168

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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