Table 4 WHO Trial registration data set

Primary registry and trial identifying number

ClinicalTrials.gov, NCT04713124

Date of registration in primary registry

19 January 2021

Secondary identifying numbers

E20/011/61428

Source(s) of monetary or material support

National Health & Medical Research Council (NHMRC) Clinical Trials and Cohort Studies (CTCS) Grant (186268).

Primary sponsor

National Health & Medical Research Council (NHMRC)

Secondary sponsor(s)

Eastern Health

Contact for public queries

Jasmin Grigg, MPH, PhD. jasmin.grigg@monash.edu

Contact for scientific queries

Jasmin Grigg, MPH, PhD. jasmin.grigg@monash.edu

Turning Point, Richmond, Victoria, 3121

Australia

Public title

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

Scientific title

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

Countries of recruitment

Australia

Health condition(s) or problem(s) studied

Methamphetamine use disorder

Intervention(s)

Active comparator: Four to six approximately weekly sessions of R2C-M telephone-delivered intervention (50 min in duration), delivered by the same R2C-M counsellor each session. Two workbooks to facilitate counsellor-delivered exercises within sessions and one self-help booklet (as in the control group).

Placebo comparator: Four to six telephone check-ins lasting ≤5 min and one self-help booklet.

Key inclusion and exclusion criteria

Ages eligible for study: ≥18 years

Sexes eligible for study: both

Accepts healthy volunteers: no

Inclusion criteria: adult patient (≥ 18 years), mild to moderate methamphetamine use disorder, used methamphetamine on at least two occasions in the past month seeking to reduce methamphetamine use, above to provide informed consent, willing to provide details of their general practitioner or other treating physician, fluent English, literacy, regular access to a telephone and willing to provide a postal or email address.

Exclusion criteria: currently receiving treatment for substance use disorder, requiring acute care for severe substance use disorder, requiring acute care for active suicidality or unstable psychiatric condition, a diagnosed primary psychotic disorder, pregnancy and hearing impairment profiting participation in telephone assessments.

Study type

Interventional

Allocation: randomised intervention model. Parallel assignment masking: double-blind (participant, outcomes assessor)

Primary purpose: treatment

Phase n/a

Date of first enrolment

February 2021

Target sample size

196 ± 8

Recruitment status

Recruiting

Primary outcome(s)

Change in methamphetamine problem severity. Measure: Drug Use Disorders Identification Test (DUDIT). Time frame: 3 months post-randomisation

Key secondary outcomes

Change in methamphetamine problem severity. Measure: DUDIT. Time frame: 6 and 12 months post-randomisation

Change in number of methamphetamine use days. Measure: Timeline Followback (TLFB). Time frame: 6 weeks and 3, 6 and 12 months post-randomisation

Change in amount of methamphetamine used. Measure: TLFB. Time frame: 6 weeks and 3, 6 and 12 months post-randomisation

Change in the number of DSM-5 methamphetamine use disorder criteria met. Measure: Structured Clinical Interview for DSM-5 Disorders - Research Version (SCID-5-RV). Time frame: 6 and 12 months post-randomisation

Change in craving for methamphetamine. Measure: Craving Experience Questionnaire (CEQ). Time frame: 6 weeks and 3, 6 and 12 months post-randomisation

Change in psychological functioning. Measure: Depression Anxiety and Stress Scale (DASS-12). Time frame: 6 weeks and 3, 6 and 12 months post-randomisation

Change in psychotic-like experiences. Measure: Community Assessment of Psychic Experiences 15 (CAPE-15). Time frame: 6 weeks and 3, 6 and 12 months post-randomisation

Change in quality of life. Measure: EUROHIS-QOL single item. Time frame: 6 weeks and 3, 6 and 12 months post-randomisation

Change in days of other drug use. Measure: TLFB. Time frame: 6 weeks and 3, 6 and 12 months post-randomisation

Difference in quality-adjusted life years (QALYs). Measure: abridged version of the 5-level EQ-5D version (EQ-5D-5L+). Time frame: over 12 months

Difference in health care costs. Measure: 3Mg Health-care Resource Use Questionnaire. Time frame: over 12 months

Difference in work-related losses. Measure: World Health Organization Health and Performance Questionnaire Clinical Trials Version (WHO HPQ28-Day). Time frame: over 12 months

Occurrence of adverse events (AEs) and significant adverse events (SAEs). Time frame: up to 6 weeks post-randomisation