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Trial registered on ANZCTR


Registration number
ACTRN12618000568213
Ethics application status
Approved
Date submitted
15/02/2018
Date registered
13/04/2018
Date last updated
26/06/2019
Date data sharing statement initially provided
16/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised (non-blinded) trial comparing the clinical efficacy of naltrexone implant plus Cognitive Behavioral Therapy versus Cognitive Behavioral Therapy in the management of problem amphetamine use
Scientific title
A randomised (non-blinded) trial comparing the clinical efficacy of naltrexone implant plus Cognitive Behavioral Therapy versus Cognitive Behavioral Therapy in the management of problem amphetamine use
Secondary ID [1] 294063 0
Nil known
Universal Trial Number (UTN)
U1111-1209-4397
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Amphetamine addiction 306619 0
Condition category
Condition code
Mental Health 305722 305722 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants assigned to the intervention group will undergo naltrexone implant treatment (O'Neil Long Acting Naltrexone Implant) and Cognitive Behavioural Therapy counseling.

O'Neil Long Acting Naltrexone Implant (OLANI)
Naltrexone implant treatment involves a minor surgical procedure which takes around 20 minutes. The implant procedure is performed by a trained clinician at the Fresh Start Recovery Programme clinic in Subiaco. During the procedure, an IV cannula is used to deliver a mild sedative, a local anaesthetic is used to numb the area and three naltrexone implants are inserted subcutaneously into the lower abdomen via a 5-15 mm incision which is then sutured and dressed with a waterproof dressing. Each naltrexone implant consists of 10 pellets, contains 1.8 g of naltrexone and has an expected in vitro release rate of 0.4-0.5% per day. After the implant procedure, participants will be monitored by a nurse for 2-4 hours before being discharged with a nominated carer. Following discharge, participants will have access to a 24 hour contact number for support and medical advice if required and access to outpatient medical services for any post implant issues. The naltrexone implant is expected to significantly reduce craving for amphetamines for around 3 to 6 months.

Cognitive Behavioural Therapy (CBT)
CBT counselling will be based on “The Cognitive-Behavioural Coping Skills Therapy Manual: A clinical research guide for therapists treating individuals for alcohol abuse and dependence” (Kadden et al., 1992) and should be delivered one-on-one and face-to-face. Counsellors will be provided with a copy of the participant information and signed consent form for their clients as well as a brief guide summarising the CBT sessions from Kadden et al.’s work, which has been extracted from Turning Point Alcohol and Drug Centre Inc’s “Clinical Treatment Guidelines for Alcohol and Drug Clinicians. No 14: Methamphetamine dependence and treatment” (Lee et al., 2007) pages 35-49, 111, 103, 81, 113, 115, 117, 119 and 121. Sessions are primarily skills bases, involving coping, problem solving and refusal skills. Participants will be advised to attend a minimum of fortnightly counselling during the 26 week assessment period, with a recommended 12 sessions (each lasting one hour) in total. Attendance and participation in counselling will be monitored by asking participants about it during fortnightly follow-up phone calls and the investigators will contact counsellor's to confirm.
Intervention code [1] 300339 0
Treatment: Drugs
Intervention code [2] 300340 0
Behaviour
Comparator / control treatment
Cognitive Behavioural Therapy (CBT)
CBT counselling will be based on “The Cognitive-Behavioural Coping Skills Therapy Manual: A clinical research guide for therapists treating individuals for alcohol abuse and dependence” (Kadden et al., 1992) and should be delivered one-on-one and face-to-face. Counsellors will be provided with a copy of the participant information and signed consent form for their clients as well as a brief guide summarising the CBT sessions from Kadden et al.’s work, which has been extracted from Turning Point Alcohol and Drug Centre Inc’s “Clinical Treatment Guidelines for Alcohol and Drug Clinicians. No 14: Methamphetamine dependence and treatment” (Lee et al., 2007) pages 35-49, 111, 103, 81, 113, 115, 117, 119 and 121. Sessions are primarily skills bases, involving coping, problem solving and refusal skills. Participants will be advised to attend a minimum of fortnightly counselling during the 26 week assessment period, with a recommended 12 sessions (each lasting one hour) in total. Attendance and participation in counselling will be monitored by asking participants about it during fortnightly follow-up phone calls and the investigators will contact counsellor's to confirm.
Control group
Active

Outcomes
Primary outcome [1] 304802 0
Number of positive weekly amphetamine/ICE urine drug screen (UDS) at 24 weeks.
Timepoint [1] 304802 0
24 weeks post recruitment.
Primary outcome [2] 304803 0
Time to return to problematic amphetamine/ICE use, defined as 3 positive UDS within a sequential four week period.
Timepoint [2] 304803 0
Participants will undergo UDS every 3-4 days for the first 4 weeks of the study, after which the frequency of UDS will be reduced to fortnightly. If at any time a UDS is positive for amphetamines, UDS frequency will be increased to every 3-4 days. If the participant returns no positive UDS for 2 consecutive weeks, UDS frequency will be reduced back to fortnightly. This will continue until 24 weeks post recruitment or until the participant returns 3 positive UDS within 4 consecutive weeks, in which case they will be considered to have returned to problematic amphetamine use on the date of the first positive UDS in the sequence.
Primary outcome [3] 304804 0
Proportion of participants who have return to problematic amphetamine/ICE use, defined as 3 positive UDS within a sequential four week period.
Timepoint [3] 304804 0
Participants will undergo UDS every 3-4 days for the first 4 weeks of the study, after which the frequency of UDS will be reduced to fortnightly. If at any time a UDS is positive for amphetamines, UDS frequency will be increased to every 3-4 days. If the participant returns no positive UDS for 2 consecutive weeks, UDS frequency will be reduced back to fortnightly. This will continue until 24 weeks post recruitment or until the participant returns 3 positive UDS within 4 consecutive weeks, in which case they will be considered to have returned to problematic amphetamine use.
Secondary outcome [1] 343230 0
Number of positive weekly amphetamine/ICE UDS at 12 weeks
Timepoint [1] 343230 0
12 weeks post recruitment
Secondary outcome [2] 344330 0
Utilisation of WA Health Services (Hospital admissions, Emergency Department presentations and Mental Health services), as determined using the hospital data systems TOPAS and Psolis.
Timepoint [2] 344330 0
Utilisation of WA Health Services will be compared for the 6 month period prior to randomisation versus the 6 month after randomisation for each treatment group.
Secondary outcome [3] 344331 0
WA Health Department costs resulting from Hospital admissions, Emergency Department (ED) presentations and utilisation of Mental Health services. Hospital
admission costs will be calculated using the average cost component per Diagnosis Related Group (DRG) using the most up-to-date AR-DRG codes. Average ED attendance cost will be based on the mean cost of an ED attendance at the Metropolitan
Health Service. Outpatient mental health costs will be calculated based on the contact time and type of professional involved, using the relevant Medicare Benefits Schedule.
Timepoint [3] 344331 0
Cost to WA Health will be compared for the 6 month period prior to randomisation versus the 6 month after randomisation for each treatment group.

Eligibility
Key inclusion criteria
Participants must be aged 18 years or older, satisfy DSM-V Substance Use Disorder diagnostic criteria for amphetamine-type stimulant use, be willing and able to provide written informed consent to participate in the randomised trial treatment, have resided in Western Australia for at least 26 weeks prior and intend to reside in Western Australia for at least 26 weeks after treatment, hold a valid Australian Medicare card and agree to undergo fortnightly urinalysis and be contacted by phone fortnightly for the 26 week duration of follow-up. Additionally, women should be using appropriate birth control and may be required to provide a negative pregnancy screen prior to recruitment .
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any person who in the last six months was or currently is enrolled in any other research study, is pregnant, breastfeeding or plans for pregnancy in the next 12 months, unable to complete the study protocol e.g. unwilling to co-operate with study follow-up, pain that requires narcotic treatment, medical disorder that in the opinion of the clinician places the subject at increased risk from any study treatment, active skin or other infection that would increase risk of infection at the site of implantation and any current major psychiatric condition preventing the patient from providing informed consent. Participants will be naltrexone implant naïve or have not undergone naltrexone implant in the previous 18 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will involve contacting the holder of the allocation schedule who is "off-site".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization method will utilise a variable block size with a unified allocation ratio.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
11/04/2019
Actual
8/04/2019
Date of last participant enrolment
Anticipated
30/08/2019
Actual
1/06/2019
Date of last data collection
Anticipated
21/02/2020
Actual
Sample size
Target
60
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 19382 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 298690 0
Government body
Name [1] 298690 0
Department of Health Western Australia
Country [1] 298690 0
Australia
Funding source category [2] 298693 0
Charities/Societies/Foundations
Name [2] 298693 0
Fresh Start Recovery Programme
Country [2] 298693 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Go Medical Industries Pty Ltd
Address
200 Churchill Avenue,
Subiaco,
Perth, WA
6008
Country
Australia
Secondary sponsor category [1] 297861 0
None
Name [1] 297861 0
Address [1] 297861 0
Country [1] 297861 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299642 0
North Metropolitan Health Service Mental Health Research Ethics and Governance Office (NMHS-MH REGO)
Ethics committee address [1] 299642 0
Ethics committee country [1] 299642 0
Australia
Date submitted for ethics approval [1] 299642 0
21/02/2018
Approval date [1] 299642 0
29/03/2018
Ethics approval number [1] 299642 0
RGS0000000937
Ethics committee name [2] 299646 0
University of Western Australia Human Research Ethics Comittee
Ethics committee address [2] 299646 0
Ethics committee country [2] 299646 0
Australia
Date submitted for ethics approval [2] 299646 0
01/05/2018
Approval date [2] 299646 0
16/10/2018
Ethics approval number [2] 299646 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81142 0
Prof Gary Hulse
Address 81142 0
Psychiatry
The University of Western Australia (M521)
35 Stirling Highway
CRAWLEY WA 6009
Australia
Country 81142 0
Australia
Phone 81142 0
+61 8 6457 2280
Fax 81142 0
Email 81142 0
gary.hulse@uwa.edu.au
Contact person for public queries
Name 81143 0
Gary Hulse
Address 81143 0
Psychiatry
The University of Western Australia (M521)
35 Stirling Highway
CRAWLEY WA 6009
Australia
Country 81143 0
Australia
Phone 81143 0
+61 8 6457 2280
Fax 81143 0
Email 81143 0
gary.hulse@uwa.edu.au
Contact person for scientific queries
Name 81144 0
Gary Hulse
Address 81144 0
Psychiatry
The University of Western Australia (M521)
35 Stirling Highway
CRAWLEY WA 6009
Australia
Country 81144 0
Australia
Phone 81144 0
+61 8 6457 2280
Fax 81144 0
Email 81144 0
gary.hulse@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.