PMID- 36991490
OWN - NLM
STAT- MEDLINE
DCOM- 20230331
LR  - 20230401
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 24
IP  - 1
DP  - 2023 Mar 29
TI  - A structured, telephone-delivered intervention to reduce methamphetamine use: 
      study protocol for a parallel-group randomised controlled trial.
PG  - 235
LID - 10.1186/s13063-023-07172-9 [doi]
LID - 235
AB  - BACKGROUND: Australia has one of the highest rates of methamphetamine (MA) use in 
      the world; however, uptake of in-person psychological treatment remains extremely 
      low due to numerous individual (e.g. stigma, shame) and structural (e.g. service 
      accessibility, geographical location) barriers to accessing care. 
      Telephone-delivered interventions are ideally placed to overcome many of the 
      known barriers to treatment access and delivery. This randomised controlled trial 
      (RCT) will examine the efficacy of a standalone, structured telephone-delivered 
      intervention to reduce MA problem severity and related harms. METHODS: This study 
      is a double-blind, parallel-group RCT. We will recruit 196 +/- 8 individuals with 
      mild to moderate MA use disorder from across Australia. After eligibility and 
      baseline assessments, participants will be randomly allocated to receive either 
      the Ready2Change-Methamphetamine (R2C-M) intervention (n = 98 +/- 4; four to six 
      telephone-delivered intervention sessions, R2C-M workbooks and MA information 
      booklet) or control (n = 98 +/- 4; four to six </=5-min telephone check-ins and MA 
      information booklet including information on accessing further support). 
      Telephone follow-up assessments will occur at 6 weeks and 3, 6 and 12 months 
      post-randomisation. The primary outcome is change in MA problem severity (Drug 
      Use Disorders Identification Test, DUDIT) at 3 months post-randomisation. 
      Secondary outcomes are as follows: MA problem severity (DUDIT) at 6 and 12 months 
      post-randomisation, amount of methamphetamine used, methamphetamine use days, 
      methamphetamine use disorder criteria met, cravings, psychological functioning, 
      psychotic-like experiences, quality of life and other drug use days (at some or 
      all timepoints of 6 weeks and 3, 6 and 12 months post-randomisation). 
      Mixed-methods program evaluation will be performed and cost-effectiveness will be 
      examined. DISCUSSION: This study will be the first RCT internationally to assess 
      the efficacy of a telephone-delivered intervention for MA use disorder and 
      related harms. The proposed intervention is expected to provide an effective, 
      low-cost, scalable treatment for individuals otherwise unlikely to seek care, 
      preventing future harms and reducing health service and community costs. TRIAL 
      REGISTRATION: ClinicalTrials.gov NCT04713124 . Pre-registered on 19 January 2021.
CI  - (c) 2023. The Author(s).
FAU - Lubman, Dan I
AU  - Lubman DI
AD  - Turning Point, Eastern Health, Melbourne, Victoria, Australia. 
      dan.lubman@monash.edu.
AD  - Monash Addiction Research Centre, Eastern Health Clinical School, Monash 
      University, Melbourne, Victoria, Australia. dan.lubman@monash.edu.
FAU - Manning, Victoria
AU  - Manning V
AD  - Turning Point, Eastern Health, Melbourne, Victoria, Australia.
AD  - Monash Addiction Research Centre, Eastern Health Clinical School, Monash 
      University, Melbourne, Victoria, Australia.
FAU - Arunogiri, Shalini
AU  - Arunogiri S
AD  - Turning Point, Eastern Health, Melbourne, Victoria, Australia.
AD  - Monash Addiction Research Centre, Eastern Health Clinical School, Monash 
      University, Melbourne, Victoria, Australia.
FAU - Hall, Kate
AU  - Hall K
AD  - School of Psychology, Deakin University, Geelong, Victoria, Australia.
AD  - Centre for Drug use, Addictive and Anti-social Behaviour Research, Deakin 
      University, Melbourne, Victoria, Australia.
FAU - Reynolds, John
AU  - Reynolds J
AD  - Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, 
      Victoria, Australia.
FAU - Stragalinos, Peta
AU  - Stragalinos P
AD  - Turning Point, Eastern Health, Melbourne, Victoria, Australia.
AD  - Monash Addiction Research Centre, Eastern Health Clinical School, Monash 
      University, Melbourne, Victoria, Australia.
FAU - Petukhova, Rachel
AU  - Petukhova R
AD  - Turning Point, Eastern Health, Melbourne, Victoria, Australia.
AD  - Monash Addiction Research Centre, Eastern Health Clinical School, Monash 
      University, Melbourne, Victoria, Australia.
FAU - Gerhard, Robyn
AU  - Gerhard R
AD  - Turning Point, Eastern Health, Melbourne, Victoria, Australia.
AD  - Monash Addiction Research Centre, Eastern Health Clinical School, Monash 
      University, Melbourne, Victoria, Australia.
FAU - Tyler, Jonathan
AU  - Tyler J
AD  - Turning Point, Eastern Health, Melbourne, Victoria, Australia.
FAU - Bough, Anna
AU  - Bough A
AD  - Turning Point, Eastern Health, Melbourne, Victoria, Australia.
FAU - Harris, Anthony
AU  - Harris A
AD  - Centre for Health Economics, Monash University, Melbourne, Victoria, Australia.
FAU - Grigg, Jasmin
AU  - Grigg J
AD  - Turning Point, Eastern Health, Melbourne, Victoria, Australia.
AD  - Monash Addiction Research Centre, Eastern Health Clinical School, Monash 
      University, Melbourne, Victoria, Australia.
LA  - eng
SI  - ClinicalTrials.gov/NCT04713124
GR  - APP1186268/National Health and Medical Research Council/
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20230329
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
SB  - IM
MH  - Humans
MH  - Treatment Outcome
MH  - Double-Blind Method
MH  - *Telephone
MH  - Australia
MH  - Cost-Benefit Analysis
MH  - Randomized Controlled Trials as Topic
PMC - PMC10052286
OTO - NOTNLM
OT  - Methamphetamine
OT  - Psychological intervention
OT  - Randomised controlled trial
OT  - Substance use disorder
OT  - Telehealth
OT  - Treatment
COIS- The authors declare that they have no competing interests.
EDAT- 2023/03/30 06:00
MHDA- 2023/03/31 06:42
PMCR- 2023/03/29
CRDT- 2023/03/29 23:53
PHST- 2022/12/21 00:00 [received]
PHST- 2023/02/14 00:00 [accepted]
PHST- 2023/03/31 06:42 [medline]
PHST- 2023/03/29 23:53 [entrez]
PHST- 2023/03/30 06:00 [pubmed]
PHST- 2023/03/29 00:00 [pmc-release]
AID - 10.1186/s13063-023-07172-9 [pii]
AID - 7172 [pii]
AID - 10.1186/s13063-023-07172-9 [doi]
PST - epublish
SO  - Trials. 2023 Mar 29;24(1):235. doi: 10.1186/s13063-023-07172-9.