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Lithium Cannabis Withdrawal Study

NCT ID: NCT00114439

Last Updated: 2007-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-09-30

Brief Summary

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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

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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.

Conditions

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Cannabis Dependence Substance Withdrawal Syndrome

Keywords

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cannabis withdrawal lithium Cannabis withdrawal syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Lithium carbonate

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of New South Wales

OTHER

Sponsor Role collaborator

Sydney South West Area Health Service

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Adam R Winstock, MBBS BSc MSc MRCP(UK) MRCP

Role: PRINCIPAL_INVESTIGATOR

Corella Drug Treatment Service

Locations

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Corella Drug Treatment Service

Fairfield, New South Wales, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type BACKGROUND
PMID: 11739594 (View on PubMed)

Other Identifiers

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UNSW HREC 04168

Identifier Type: -

Identifier Source: secondary_id

SSWAHS HREC 2005/047

Identifier Type: -

Identifier Source: org_study_id