Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Government body
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00114439