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Cannabis DependencePhase 2NCT00114439

Lithium Cannabis Withdrawal Study

A Phase 2 study testing Lithium carbonate in people with Cannabis Dependence and Substance Withdrawal Syndrome, run by Sydney South West Area Health Service at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
What is being tested?
Lithium carbonate
How many people
25 participants
Where
1 siteAustralia
Study dates
Sep 2005to Sep 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Australia1 site

  • Corella Drug Treatment Service

    Fairfield, New South Wales, 2176

Other trials in Australia

About this study

Official title: An Open Label Trial of Lithium for the Management of Cannabis Withdrawal

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.

Read the 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.

Being tested
Lithium carbonate
Keywords
cannabis withdrawal, lithium, Cannabis withdrawal syndrome
Medical subject headings
Marijuana Abuse, Substance Withdrawal Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lithium carbonateDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Severity of reported cannabis withdrawal symptoms

  2. Treatment retention

  3. Cannabis use

  4. Depression

  5. Anxiety

  6. Aggression/Anger

  7. Sleep difficulty

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2005 (estimated)
  2. Study startSep 2005
  3. Study completionSep 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00114439
Sponsor's protocol ID
SSWAHS HREC 2005/047
Other IDs
UNSW HREC 04168
Status last verified
Sep 2007
First submitted
14 Jun 2005
Last updated
27 Sep 2007
Results posted
No

Publications

  • 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.

    PubMed 11739594

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lithium carbonate in people with Cannabis Dependence and Substance Withdrawal Syndrome, run by Sydney South West Area Health Service at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severity of reported cannabis withdrawal symptoms. The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00114439, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2007.

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