A Telephone-delievered Intervention to Reduce Methamphetamine Use

NCT04713124 | Completed

• 1 other identifier: E20/011/61428
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Methamphetamine Use Disorder

Outcome Measures

Primary Outcomes (1)

• Methamphetamine problem severity

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

  3-months post-randomisation

Secondary Outcomes (13)

• Methamphetamine problem severity

  6- and 12-months post-randomisation

• Number of methamphetamine use days

  6 weeks, and 3-, 6- and 12-months post-randomisation

• Amount of methamphetamine used

  6 weeks, and 3-, 6- and 12-months post-randomisation

• Number of DSM-5 methamphetamine use disorder criteria met

  3-, 6- and 12-months post-randomisation

• Methamphetamine craving

  6 weeks, and 3-, 6- and 12-months post-randomisation

Other Outcomes (1)

• Program evaluation

  Through study completion, approximately 28 months

Study Arms (2)

R2C-M intervention

EXPERIMENTAL

R2C-M telephone intervention - Six approximately weekly sessions of R2C-M telephone-delivered intervention (50 minutes in duration), delivered by the same R2C-M Counsellor each session (a qualified clinical psychologist trained in the R2C protocol by the developer, Dr Kate Hall). Call duration will be recorded. Sessions will be digitally recorded, and an independent researcher will randomly select and rate fidelity of intervention sessions for 20% of participants. R2C-M workbooks - Two workbooks to facilitate counsellor-delivered exercises within sessions, and between-session practice, will be mailed/emailed to participants. Self-help booklet - (as in control group) R2C-M participants will also receive a booklet of information and self-help strategies for methamphetamine use problems.

Behavioral: R2C-M; Other: Self-help booklet

Control

ACTIVE COMPARATOR

Self-help booklet - Control participants will receive (by mail/email) a booklet of information and self-help strategies for methamphetamine use problems. Telephone check-ins + information on further support - (to control for frequency of contact across treatment arms) Participants in this group will receive 6 telephone calls from the research team (lasting maximum 5 minutes, call duration will be recorded). During these calls, participants will be asked about their use of the booklet. Whenever required, the researcher will provide participants with information on further support (e.g. DirectLine or other state/territory AOD helpline for advice or referral).

Other: Self-help booklet

Interventions

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.

R2C-M intervention

Self-help booklet OTHER

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

Control; R2C-M intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turning Point: lead
• Eastern Health: collaborator
• Monash University: collaborator
• Deakin University: collaborator

Study Sites (1)

Turning Point

Richmond, Victoria, 3121, Australia

Location

Related Publications (1)

• Lubman DI, Manning V, Arunogiri S, Hall K, Reynolds J, Stragalinos P, Petukhova R, Gerhard R, Tyler J, Bough A, Harris A, Grigg J. A structured, telephone-delivered intervention to reduce methamphetamine use: study protocol for a parallel-group randomised controlled trial. Trials. 2023 Mar 29;24(1):235. doi: 10.1186/s13063-023-07172-9.

  PMID: 36991490 DERIVED

Study Officials

• Dan I Lubman

  Turning Point, Eastern Health; Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 19, 2021
• Study Start: February 4, 2021
• Primary Completion: May 1, 2023
• Study Completion: January 25, 2024
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)