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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00114439




Registration number
NCT00114439
Ethics application status
Date submitted
14/06/2005
Date registered
15/06/2005
Date last updated
27/09/2007

Titles & IDs
Public title
Lithium Cannabis Withdrawal Study
Scientific title
An Open Label Trial of Lithium for the Management of Cannabis Withdrawal
Secondary ID [1] 0 0
UNSW HREC 04168
Secondary ID [2] 0 0
SSWAHS HREC 2005/047
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cannabis Dependence 0 0
Substance Withdrawal Syndrome 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lithium carbonate

Treatment: Drugs: Lithium carbonate
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Severity of reported cannabis withdrawal symptoms
Timepoint [1] 0 0
Primary outcome [2] 0 0
Treatment retention
Timepoint [2] 0 0
Primary outcome [3] 0 0
Cannabis use
Timepoint [3] 0 0
Primary outcome [4] 0 0
Depression
Timepoint [4] 0 0
Primary outcome [5] 0 0
Anxiety
Timepoint [5] 0 0
Primary outcome [6] 0 0
Aggression/Anger
Timepoint [6] 0 0
Primary outcome [7] 0 0
Sleep difficulty
Timepoint [7] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2006
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Corella Drug Treatment Service - Fairfield
Recruitment postcode(s) [1] 0 0
2176 - Fairfield

Funding & Sponsors
Primary sponsor type
Other
Name
Sydney South West Area Health Service
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of New South Wales
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00114439
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Adam R Winstock, MBBS BSc MSc MRCP(UK) MRCP
Address 0 0
Corella Drug Treatment Service
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries