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Lithium Cannabis Withdrawal Study

Primary Purpose

Cannabis Dependence, Substance Withdrawal Syndrome

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Lithium carbonate
Sponsored by
Sydney South West Area Health Service
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Dependence focused on measuring cannabis withdrawal, lithium, Cannabis withdrawal syndrome

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Corella Drug Treatment Service

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 14, 2005
Last Updated
September 26, 2007
Sponsor
Sydney South West Area Health Service
Collaborators
The University of New South Wales
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1. Study Identification

Unique Protocol Identification Number
NCT00114439
Brief Title
Lithium Cannabis Withdrawal Study
Official Title
An Open Label Trial of Lithium for the Management of Cannabis Withdrawal
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sydney South West Area Health Service
Collaborators
The University of New South Wales

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Dependence, Substance Withdrawal Syndrome
Keywords
cannabis withdrawal, lithium, Cannabis withdrawal syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lithium carbonate
Primary Outcome Measure Information:
Title
Severity of reported cannabis withdrawal symptoms
Title
Treatment retention
Title
Cannabis use
Title
Depression
Title
Anxiety
Title
Aggression/Anger
Title
Sleep difficulty

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam R Winstock, MBBS BSc MSc MRCP(UK) MRCP
Organizational Affiliation
Corella Drug Treatment Service
Official's Role
Principal Investigator
Facility Information:
Facility Name
Corella Drug Treatment Service
City
Fairfield
State/Province
New South Wales
ZIP/Postal Code
2176
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
11739594
Citation
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.
Results Reference
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Lithium Cannabis Withdrawal Study

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