Lithium Cannabis Withdrawal Study
An Open Label Trial of Lithium for the Management of Cannabis Withdrawal
2 other identifiers
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2005
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2005
CompletedFirst Posted
Study publicly available on registry
June 15, 2005
CompletedStudy Start
First participant enrolled
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedSeptember 27, 2007
September 1, 2007
June 14, 2005
September 26, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Severity of reported cannabis withdrawal symptoms
Treatment retention
Cannabis use
Depression
Anxiety
Aggression/Anger
Sleep difficulty
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Corella Drug Treatment Service
Fairfield, New South Wales, 2176, Australia
Related 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. doi: 10.1523/JNEUROSCI.21-24-09867.2001.
PMID: 11739594BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam R Winstock, MBBS BSc MSc MRCP(UK) MRCP
Corella Drug Treatment Service
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
June 14, 2005
First Posted
June 15, 2005
Study Start
September 1, 2005
Study Completion
September 1, 2006
Last Updated
September 27, 2007
Record last verified: 2007-09