Methamphetamine Use Disorder
Conditions
Brief summary
Australia has one of the highest rates of methamphetamine use in the world; however, uptake of face-to-face psychological treatment remains extremely low due to numerous individual (e.g. stigma, shame) and structural (e.g. service availability, geography) barriers to accessing care. Addressing these barriers through the provision of alternative treatment delivery models is imperative, particularly as effective and earlier intervention is likely to reduce the need for more costly and intensive treatment resulting from escalating methamphetamine use. In this project, the investigators will conduct the first double-blind, parallel-group, randomised controlled trial (RCT) examining the effectiveness of the structured telephone-delivered intervention, Ready2Change (R2C), among participants with methamphetamine use problems (R2C-M). Cost effectiveness of R2C-M will also be investigated. Factors influencing program implementation will be evaluated to inform the scalability of this intervention for practice nationally, and for replication internationally.
Interventions
BEHAVIORALR2C-M
R2C-M comprises 12 modules addressing core practice elements and skills from evidence-based cognitive and behavioural interventions. Modules include: (i) self-monitoring, goal setting and behaviour change skills; (ii) identification of strengths and motivational enhancement; (iii) relapse prevention; (iv) psychoeducation and harm reduction; (v) emotion regulation skills; (vi) anger management skills; (vii) urges and cravings management skills; (viii) sleep hygiene skills; (ix) mindfulness skills; (x) interpersonal skills; (xi) anxiety management skills; (xii) depressed mood management skills. The R2C-M workbooks contain psychoeducation and intervention exercises, to facilitate counsellor-delivered exercises within sessions, and between-session practice.
OTHERSelf-help booklet
A booklet of information and self-help strategies for methamphetamine use problems.
Sponsors
Eastern Health
Monash University
Deakin University
Turning Point
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18+ years * Mild or moderate methamphetamine use disorder (DSM-5 diagnosis confirmed at baseline assessment using the Structured Clinical Interview for DSM-5 Disorders - Research Version, SCID-5-RV) * Used methamphetamine on at least two occasions in the past month * Seeking to reduce methamphetamine use * Able to provide informed consent, and comply with the requirements of the treatment protocol * Willing to provide the contact details of their general practitioner or other treating physician, for follow-up * English as a first language or fluent * Educated to high school level (literacy) * Regular access to a telephone * Postal/email address to receive intervention materials
Exclusion criteria
* Currently receiving treatment for substance use disorder (e.g. medically supervised detoxification, residential rehabilitation, drug counselling, pharmacotherapy - this criterion applies only at trial enrolment, and does not preclude the participant from entering treatment/receiving usual care during the trial) * Requiring acute care for severe substance use disorder (DSM-5 diagnosis confirmed at baseline using the SCID-5-RV, with oversight from the Principal Investigator or Study Clinician) * Requiring acute care for active suicidality or unstable psychiatric condition * A diagnosed primary psychotic disorder (schizophrenia, schizoaffective disorder, bipolar disorder) * Pregnancy * Hearing impairment that would prohibit participation in telephone intervention / follow-up assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Methamphetamine problem severity | 3-months post-randomisation | Change in methamphetamine problem severity (Drug Use Disorders Identification Test; DUDIT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of methamphetamine used | 6 weeks, and 3-, 6- and 12-months post-randomisation | Change in amount of methamphetamine used (TLFB) |
| Methamphetamine problem severity | 6- and 12-months post-randomisation | Change in methamphetamine problem severity (DUDIT) |
| Number of methamphetamine use days | 6 weeks, and 3-, 6- and 12-months post-randomisation | Change in number of methamphetamine use days (Timeline Followback; TLFB) |
| Number of DSM-5 methamphetamine use disorder criteria met | 3-, 6- and 12-months post-randomisation | Change in the number of DSM-5 methamphetamine use disorder criteria met (Structured Clinical Interview for DSM-5 Disorders - Research Version; SCID-5-RV) |
| Methamphetamine craving | 6 weeks, and 3-, 6- and 12-months post-randomisation | Change in craving for methamphetamine (Craving Experience Questionnaire; CEQ) |
| Psychological functioning | 6 weeks, and 3-, 6- and 12-months post-randomisation | Change in psychological functioning (Depression Anxiety and Stress Scale; DASS-12) |
| Quality of life | 6 weeks, and 3-, 6- and 12-months post-randomisation | Change in quality of life (EUROHIS-QOL single item) |
| Days of other drug use | 6 weeks, and 3-, 6- and 12-months post-randomisation | Change in days of other drug use (TLFB) |
| Cost-effectiveness - QALYs | Over 12 months | Difference in quality-adjusted life years (QALYs) (abridged version of the 5-level EQ-5D version, EQ-5D-5L+) |
| Cost-effectiveness - health care costs | Over 12 months | Difference in health care costs (3Mg Health-care Resource Use Questionnaire) |
| Cost-effectiveness - work-related losses | Over 12 months | Difference in work-related losses (World Health Organization Health and Performance Questionnaire Clinical Trials Version; WHO HPQ28-Day) |
| Adverse events | Up to 6 weeks post-randomisation | Occurrence of adverse events (AEs) and significant adverse events (SAEs) |
| Psychotic-like experiences | 6 weeks, and 3-, 6- and 12-months post-randomisation | Change in psychotic-like experiences (Community Assessment of Psychic Experiences 15, CAPE15) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Program evaluation | Through study completion, approximately 28 months | Mixed-methods program evaluation (Glasgow et al.'s RE-AIM framework) |
Countries
Australia
Outcome results
None listed