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Completed

NCT Number: NCT04713124

A Telephone-delievered Intervention to Reduce Methamphetamine Use

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.

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Key information

Conditions

Methamphetamine Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Turning Point

Richmond, Victoria, 3121, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

R2C-M

Behavioral

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.

Self-help booklet

Other

A booklet of information and self-help strategies for methamphetamine use problems.

Primary outcomes

  1. Methamphetamine problem severity

    Time frame: 3-months post-randomisation

    Change in methamphetamine problem severity (Drug Use Disorders Identification Test; DUDIT)

Secondary outcomes

  1. Methamphetamine problem severity

    Time frame: 6- and 12-months post-randomisation

    Change in methamphetamine problem severity (DUDIT)

  2. Number of methamphetamine use days

    Time frame: 6 weeks, and 3-, 6- and 12-months post-randomisation

    Change in number of methamphetamine use days (Timeline Followback; TLFB)

  3. Amount of methamphetamine used

    Time frame: 6 weeks, and 3-, 6- and 12-months post-randomisation

    Change in amount of methamphetamine used (TLFB)

  4. Number of DSM-5 methamphetamine use disorder criteria met

    Time frame: 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)

  5. Methamphetamine craving

    Time frame: 6 weeks, and 3-, 6- and 12-months post-randomisation

    Change in craving for methamphetamine (Craving Experience Questionnaire; CEQ)

  6. Psychological functioning

    Time frame: 6 weeks, and 3-, 6- and 12-months post-randomisation

    Change in psychological functioning (Depression Anxiety and Stress Scale; DASS-12)

  7. Psychotic-like experiences

    Time frame: 6 weeks, and 3-, 6- and 12-months post-randomisation

    Change in psychotic-like experiences (Community Assessment of Psychic Experiences 15, CAPE15)

  8. Quality of life

    Time frame: 6 weeks, and 3-, 6- and 12-months post-randomisation

    Change in quality of life (EUROHIS-QOL single item)

  9. Days of other drug use

    Time frame: 6 weeks, and 3-, 6- and 12-months post-randomisation

    Change in days of other drug use (TLFB)

  10. Cost-effectiveness - QALYs

    Time frame: Over 12 months

    Difference in quality-adjusted life years (QALYs) (abridged version of the 5-level EQ-5D version, EQ-5D-5L+)

  11. Cost-effectiveness - health care costs

    Time frame: Over 12 months

    Difference in health care costs (3Mg Health-care Resource Use Questionnaire)

  12. Cost-effectiveness - work-related losses

    Time frame: Over 12 months

    Difference in work-related losses (World Health Organization Health and Performance Questionnaire Clinical Trials Version; WHO HPQ28-Day)

  13. Adverse events

    Time frame: Up to 6 weeks post-randomisation

    Occurrence of adverse events (AEs) and significant adverse events (SAEs)

Other outcomes

  1. Program evaluation

    Time frame: Through study completion, approximately 28 months

    Mixed-methods program evaluation (Glasgow et al.'s RE-AIM framework)

Sponsors and collaborators

Lead sponsor

Turning Point

Other

Collaborators

  • Deakin University
  • Eastern Health
  • Monash University

Registry information

Official study title

Ready2Change-Methamphetmine (R2C-M): A Randomised Controlled Trial of a Telephone-delivered Intervention to Reduce Methamphetamine Use

Acronym: R2C-M

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jan 19, 2021
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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