Lithium Cannabis Withdrawal Study

Cannabis Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00114439
• Other study ID #: SSWAHS HREC 2005/047
• Secondary ID: UNSW HREC 04168
• Status: Completed
• Phase: Phase 2
• First received: June 14, 2005
• Last updated: September 26, 2007
• Start date: September 2005
• Est. completion date: September 2006

Study information

• Verified date: September 2007
• Source: Sydney South West Area Health Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Cannabis Dependence
• Marijuana Abuse
• Substance Withdrawal Syndrome

Intervention

Drug:
• Lithium carbonate

Locations

Country	Name	City	State
Australia	Corella Drug Treatment Service	Fairfield	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Sydney South West Area Health Service	The University of New South Wales

Country where clinical trial is conducted

Australia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of reported cannabis withdrawal symptoms
Primary	Treatment retention
Primary	Cannabis use
Primary	Depression
Primary	Anxiety
Primary	Aggression/Anger
Primary	Sleep difficulty