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

• Register: ANZCTR
• Last refreshed on: 15 July 2019
• Main ID: ACTRN12618000568213
• Date of registration: 13/04/2018
• Prospective Registration: Yes
• Primary sponsor: Go Medical Industries Pty Ltd
• 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
• Date of first enrolment: 08/04/2019
• Target sample size: 60
• Recruitment status: Suspended
• URL: https://anzctr.org.au/ACTRN12618000568213.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 2

Countries of recruitment

Australia

Contacts

• Name: Prof Gary Hulse

• Name: Prof Gary Hulse

Key inclusion & exclusion criteria

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 .
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.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Mental Health - Addiction

Amphetamine addiction;
Amphetamine addiction

Intervention(s)

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

Primary Outcome(s)

Time to return to problematic amphetamine/ICE use, defined as 3 positive UDS within a sequential four week period.
[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.]

Number of positive weekly amphetamine/ICE urine drug screen (UDS) at 24 weeks.
[24 weeks post recruitment.]

Proportion of participants who have return to problematic amphetamine/ICE use, defined as 3 positive UDS within a sequential four week period.
[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(s)

Number of positive weekly amphetamine/ICE UDS at 12 weeks
[12 weeks post recruitment ]

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.[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. ]

Utilisation of WA Health Services (Hospital admissions, Emergency Department presentations and Mental Health services), as determined using the hospital data systems TOPAS and Psolis.[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 ID(s)

Nil known

Source(s) of Monetary Support

Department of Health Western Australia

Fresh Start Recovery Programme

Ethics review

Status: Approved
Approval date:
Contact:

North Metropolitan Health Service Mental Health Research Ethics and Governance Office (NMHS-MH REGO)

Status: Approved
Approval date:
Contact:

University of Western Australia Human Research Ethics Comittee