Lithium Cannabis Withdrawal Study | NCT00114439

Studies
Lithium Cannabis Withdrawal Study

NCT00114439

Sponsor

Sydney South West Area Health Service

Status

Completed

Last Update Posted

Sep 27, 2007Estimated

Enrollment

25Estimated

Phase

Phase 2

Conditions

Cannabis Dependence
Substance Withdrawal Syndrome

Interventions

Lithium carbonate

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UNSW HREC 04168

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Not provided

Completion Date

Sep 2006Actual

First Submitted Date

Jun 14, 2005

First Submission Date that Met QC Criteria

Jun 14, 2005

First Posted Date

Jun 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2007

Last Update Posted Date

Sep 27, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Sydney South West Area Health ServiceOTHER_GOV

Collaborators

Name	Class
The University of New South Wales	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Name	Type	Description	Arm Group Labels	Other Names
Lithium carbonate	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Severity of reported cannabis withdrawal symptoms
Treatment retention
Cannabis use
Depression
Anxiety
Aggression/Anger
Sleep difficulty

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adam R Winstock, MBBS BSc MSc MRCP(UK) MRCP	Corella Drug Treatment Service	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Corella Drug Treatment Service		Fairfield	New South Wales	2176	Australia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11739594	Background	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.

ID	Term
D002189	Marijuana Abuse
D013375	Substance Withdrawal Syndrome

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

ID	Term
D002254	Carbonates
D000468	Alkalies
D007287	Inorganic Chemicals
D002255	Carbonic Acid