Trial from ANZCTR


Trial ID ACTRN12611000398909
Trial Status: Registered
Date Submitted: 12/04/2011
Date Registered: 15/04/2011
Prospectively registered

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Public title Double blind, randomised, placebo controlled trial of Sativex for the management of cannabis withdrawal
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Double blind, randomised, placebo controlled trial of Sativex for the management of cannabis withdrawal
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Secondary ID [1] 259990 0
Nil
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UTN U1111-1120-7086
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Trial acronym
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Health condition(s) or problem(s) studied:
Cannabis withdrawal 265620 0
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Condition category: Condition code:
Public Health Health service research
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265768 265768 0 0
Mental Health Addiction
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Descriptions of intervention(s) / exposure Investigational drug: Sativex (1 spray: 2.7 mg THC and 2.5 mg CBD) in an alcohol and peppermint oil liquid administered as an oromucosal spray onto the inside of the mouth (but not intended to be swallowed and digested through the stomach - so some time (1 minute) should be taken after each single spray is administered to ensure absorption, before the next spray is administered). The patient cannot choose when they receive their 8 spray dose, they must have them all at the 6 hourly interval.

Dosage form/strength: maximum 800 uL every six hours (X8 sprays every six hours). Participants may not take partial doses (i.e. 6 sprays) but they can ask to miss up to two of the 6 hourly dose in a day. Patients are in hospital for 8 nights, discharging on day 9.
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Intervention Code:
Treatment: drugs 264405 0
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Comparator / control treatment Placebo spray - comprising alcohol and peppermint oil
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Control group Placebo
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Primary Outcome: Self-reported measures of cannabis withdrawal using the Cannabis Withdrawal Scale (a modified version of the MWC (Budney et al., 1999)). 266522 0
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Timepoint: Four times a day for 9 days (6am, 11 am, 6pm and 10pm) 266522 0
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Primary Outcome: Treatment completion, defined as completing 9 days of inpatient treatment under protocol conditions (categorical yes/no); and number of days of inpatient treatment completed (range: 0-9). 266523 0
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Timepoint: Quantified once on day of patient discharge from hospital 266523 0
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Primary Outcome: Adverse events during the inpatient treatment period using a tailor made Adverse Events Checklist and administered by clinician/nurse/medical officer. Adverse events may include any of the following: Dizziness, Dry mouth, Tachycardia, Stomache ache, Slowed motor skills, slowed reaction time, anxiety, dysphoria, paranoia, oro-mucosal ulceration. Adverse events will be rated on a 0 - 3 scale, 0 being None, 1 being Mild, 2 being Moderate, 3 being Severe. 266524 0
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Timepoint: Once daily for the 9 days of inpatient stay 266524 0
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Secondary Outcome: Self-reported cannabis use with total days used cannabis (range 0-28) and longest period of continuous abstinence (range 0-28) during the one month follow-up period (quantifying rates of continuous and point prevalence abstinence from cannabis, time to relapse, levels of cannabis use, and cannabis related problems at follow up), using the Timeline Followback method 273957 0
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Timepoint: At baseline (day 1 of entry into inpatient unit) for the previous 28 days, and at follow up (28 days after discharge from hospital) 273957 0
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Secondary Outcome: Urine Carboxy-THC: creatinine ratio using Gas Chromatography/Mass Spectrometry 273958 0
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Timepoint: At baseline (day 1 of entry into inpatient unit), daily during 9 day inpatient stay and at follow up (28 days after discharge from hospital) 273958 0
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Secondary Outcome: Blood plasma profiles of cannabinoid metabolites (THC and its primary metabolite (THC-COOH) to CBD and its primary metabolite (CBD-7-oic acid)) 273959 0
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Timepoint: Day 1 of intake to the inpatient unit(pre-sativex). And the same measures taken after Sativex has been administered to participants (taken on days 3 and 7). 273959 0
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Secondary Outcome: Cannabis Problems Questionnaire (Copeland, Gilmour, Gates, & Swift, 2005) 273960 0
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Timepoint: Baseline (Day 1) and Follow up (28 days after discharge) 273960 0
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Secondary Outcome: Brief Treatment Outcome Measure-Social Functioning Scale (Lawrinson, Copeland, & Indig, 2005) 273961 0
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Timepoint: Baseline (Day 1) and Follow up (28 days after discharge) 273961 0
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Secondary Outcome: Insomnia severity index (Bastien, Vallieres, & Morin, 2001) 273962 0
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Timepoint: Baseline (Day 1), Discharge (Day 9) and Follow up (28 days after discharge) 273962 0
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Secondary Outcome: Cannabis Dependence using the Severity of Dependence Scale (SDS) (Martin, Copeland, Gates, & Gilmour, 2006; Swift, Copeland, & Hall, 1998) 273963 0
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Timepoint: Baseline (Day 1), Discharge (Day 9) and Follow up (28 days after discharge) 273963 0
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Secondary Outcome: Depression, Anxiety and Stress measures using the 21 item version of the Depression, Anxiety and Stress Scale (Lovibond & Lovibond, 1995) 273964 0
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Timepoint: Baseline (Day 1), Discharge (Day 9) and Follow up (28 days after discharge) 273964 0
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Secondary Outcome: Quality of life using the Sheehan Disability Scale 273965 0
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Timepoint: Baseline (Day 1) and Follow up (28 days after discharge) 273965 0
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Secondary Outcome: Self efficacy for Quitting Cannabis Questionnaire 273966 0
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Timepoint: Baseline (Day 1), Discharge (Day 9) and Follow up (28 days after discharge) 273966 0
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Secondary Outcome: Anxiety Sensitivity Index 273967 0
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Timepoint: Baseline (Day 1) and Follow up (28 days after discharge) 273967 0
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Secondary Outcome: Distress tolerance Scale 273968 0
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Timepoint: Baseline (Day 1) and Follow up (28 days after discharge) 273968 0
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Key inclusion criteria 1. Between 18-65 years of age (Both males and females)
2. Regular recent cannabis use (average of 5 times per week – self report)
3. Meet DSM-IV-TR 'Registered Trademark' criteria for cannabis dependence
4. Has made unsuccessful quit attempts in the past
5. Desire to give up cannabis
6. Prepared to enter a hospital ward for 9 days

If NO to any (1 - 6) client is not eligible for SATIVEX trial phone screen, provide usual referral/treatment advice.
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Minimum age 18 Years
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Maximum age 65 Years
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria 1. More than twice weekly use of an illicit drug in the last 30 days (other than cannabis)
2. Dependence on a substance other than cannabis and tobacco
3. Pregnant or breastfeeding
4. Female of child bearing potential NOT using contraception
5. Evidence of severe medical impairment (e.g. chronic pain, severe hepatic impairment or cardiovascular disease)
6. Evidence of severe cognitive or psychiatric impairment (e.g. bipolar, schizophrenia, suicidal ideation)
7. Current (within past month) prescription for antipsychotic or mood stabilising medications
8. Currently prescribed warfarin
9. Allergy to cannabinoids, propylene glycol, ethanol or peppermint oil
10. Not English literate
11. Specialist substance use treatment in the last 30 days
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Allocation involves contacting the holder of the allocation schedule who was "off-site" or at central administration
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Permuted block randomisation
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features Participants receive either Sativex or Placebo - never both, and participants are anticipated to come into the study one at a time (at each of the two study sites)
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Type of endpoint(s) Safety/efficacy
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Statistical Methods/Analysis
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Phase Phase 2
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Anticipated date of first participant enrolment 31/07/2011
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 50
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Recruitment status Not yet recruiting
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Recruitment in Australia

Recruitment state(s)
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Postcode: 2000 3921 0
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Postcode: 2300 3922 0
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Recruitment outside Australia

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Funding Source: Government body 264870 0
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Name: National Health and Medical Research Council 264870 0
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Address: Level 1
16 Marcus Clarke Street
Canberra ACT 2601
264870 0
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Country: Australia 264870 0
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Primary Sponsor University
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Name: University of New South Wales
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Address: The University of New South Wales
SYDNEY
NSW 2052
AUSTRALIA
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Country: Australia
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Secondary Sponsor: None 263971 0
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Other Collaborator: Hospital 251941 0
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Name: Belmont District Hospital 251941 0
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Address: Croudace Bay Road, Belmont NSW 2280 251941 0
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Country: Australia 251941 0
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Other Collaborator: Hospital 251942 0
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Name: Sydney & Sydney Eye Hospital 251942 0
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Address: GPO Box 1614, Sydney NSW 2001 Australia 251942 0
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Country: Australia 251942 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Hunter New England Research Ethics Committee 266831 0
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Address: Locked Bag No 1
New Lambton, NSW 2305
266831 0
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Country: Australia 266831 0
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Approval Date: 02/02/2011 266831 0
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Submitted Date: 266831 0
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HREC: 10/12/15/3.02 266831 0
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Brief summary The primary objective of the study is to examine the safety and efficacy of SATIVEX 'Registered Trademark (R)' in the inpatient management of cannabis withdrawal, in a double blinded randomised trial compared to placebo. Specifically, the study will compare withdrawal severity, detoxification completion and adverse events between the two conditions in an intention-to-treat analysis. Secondary objectives include 1-month post-withdrawal outcomes (including cannabis and other drug use and psychosocial outcomes), and to assess the relationship between the number, severity and duration of cannabis withdrawal symptoms and rates of continuous and point prevalence abstinence from cannabis, time to relapse, levels of cannabis use, and cannabis related problems at one month follow-up. The study will also explore the cognitive impact of withdrawing from cannabis, as well as the impact of SATIVEX on cognitive functioning, with an aim to assessing the real world safety profile of the drug ahead of larger outpatient studies. The study will also explore the pharmacokinetics and metabolites associated with SATIVEX (R) administration to develop a protocol for differentiating between SATIVEX(R) and illicit cannabis in blood or urine among those entering cannabis withdrawal treatment. This pharmacokinetic assay will prove useful for future large scale outpatient trials should the current trial prove successful. A final exploratory objective of the study is to determine whether there is evidence of an interaction with the efficacy of SATIVEX(R) and patient characteristics on admission (including demographics and cannabis and other use and psychosocial factors such as treatment expectancy) on reported severity of cannabis withdrawal and subsequent post-withdrawal outcomes (cannabis use, psychosocial outcomes, sleep disturbances and cannabis-related problems) to be fully tested in a larger community study.
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Trial website
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Professor Jan Copeland
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Address: National Cannabis Prevention and Information Centre, NDARC, UNSW, Sydney NSW, 2052, Australia
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Email: j.copeland@unsw.edu.au
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Contact person for scientific queries
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Name: Professor Jan Copeland
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Address: National Cannabis Prevention and Information Centre, NDARC, UNSW, Sydney NSW, 2052, Australia
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Email: j.copeland@unsw.edu.au
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Contact person responsible for updating information
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Name: Dr David Allsop
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Address: National Cannabis Prevention and Information Centre, NDARC, UNSW, Sydney NSW, 2052, Australia
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Country: Australia
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Tel: +61 2 9385 0448
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Addition Cancer fields
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