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
Go Medical Industries Pty Ltd
60 participants
Apr 8, 2019
Interventional
Conditions
Summary
The study aims to investigate whether treatment with long-acting naltrexone implant (OLANI) as well as counselling is more effective than just counselling for preventing relapse to regular amphetamine use. Additionally, we are investigating the effect of naltrexone implant treatment on utilisation of WA Health Services (Hospital admissions, Emergency Department presentations and Mental Health services) in order to assess cost savings and cost effectiveness.
Eligibility
Inclusion Criteria1
- 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 Criteria1
- 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.
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Interventions
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.
Locations(1)
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ACTRN12618000568213