A Telephone-delievered Intervention to Reduce Methamphetamine Use

Methamphetamine Use Disorder Clinical Trial

— R2C-M  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04713124
• Other study ID #: E20/011/61428
• Status: Completed
• Phase: N/A
• Start date: February 4, 2021
• Est. completion date: January 25, 2024

Study information

• Verified date: April 2024
• Source: Turning Point
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: January 25, 2024
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Methamphetamine Use Disorder

Intervention

Behavioral:
• R2C-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.

Other:
• Self-help booklet
A booklet of information and self-help strategies for methamphetamine use problems.

Locations

Country	Name	City	State
Australia	Turning Point	Richmond	Victoria

Sponsors (4)

Lead Sponsor	Collaborator
Turning Point	Deakin University, Eastern Health, Monash University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Program evaluation	Mixed-methods program evaluation (Glasgow et al.'s RE-AIM framework)	Through study completion, approximately 28 months
Primary	Methamphetamine problem severity	Change in methamphetamine problem severity (Drug Use Disorders Identification Test; DUDIT)	3-months post-randomisation
Secondary	Methamphetamine problem severity	Change in methamphetamine problem severity (DUDIT)	6- and 12-months post-randomisation
Secondary	Number of methamphetamine use days	Change in number of methamphetamine use days (Timeline Followback; TLFB)	6 weeks, and 3-, 6- and 12-months post-randomisation
Secondary	Amount of methamphetamine used	Change in amount of methamphetamine used (TLFB)	6 weeks, and 3-, 6- and 12-months post-randomisation
Secondary	Number of DSM-5 methamphetamine use disorder criteria met	Change in the number of DSM-5 methamphetamine use disorder criteria met (Structured Clinical Interview for DSM-5 Disorders - Research Version; SCID-5-RV)	3-, 6- and 12-months post-randomisation
Secondary	Methamphetamine craving	Change in craving for methamphetamine (Craving Experience Questionnaire; CEQ)	6 weeks, and 3-, 6- and 12-months post-randomisation
Secondary	Psychological functioning	Change in psychological functioning (Depression Anxiety and Stress Scale; DASS-12)	6 weeks, and 3-, 6- and 12-months post-randomisation
Secondary	Psychotic-like experiences	Change in psychotic-like experiences (Community Assessment of Psychic Experiences 15, CAPE15)	6 weeks, and 3-, 6- and 12-months post-randomisation
Secondary	Quality of life	Change in quality of life (EUROHIS-QOL single item)	6 weeks, and 3-, 6- and 12-months post-randomisation
Secondary	Days of other drug use	Change in days of other drug use (TLFB)	6 weeks, and 3-, 6- and 12-months post-randomisation
Secondary	Cost-effectiveness - QALYs	Difference in quality-adjusted life years (QALYs) (abridged version of the 5-level EQ-5D version, EQ-5D-5L+)	Over 12 months
Secondary	Cost-effectiveness - health care costs	Difference in health care costs (3Mg Health-care Resource Use Questionnaire)	Over 12 months
Secondary	Cost-effectiveness - work-related losses	Difference in work-related losses (World Health Organization Health and Performance Questionnaire Clinical Trials Version; WHO HPQ28-Day)	Over 12 months
Secondary	Adverse events	Occurrence of adverse events (AEs) and significant adverse events (SAEs)	Up to 6 weeks post-randomisation