The Tina Trial: A trial of mirtazapine for methamphetamine dependence

Conditions

None listed

Brief summary

This is a multi-site randomised placebo-controlled trial of mirtazapine (30 mg/day for 12 weeks) for methamphetamine dependence. We hypothesise that mirtazapine will reduce methamphetamine use, reduce depression, improve sleep, improve quality of life and reduce HIV risk. We will also examine safety and tolerability of mirtazapine when delivered in routine clinical care in Australia.

McKetin R, Shoptaw S, Saunders L, Nguyen L, Clare PJ, Dore GJ, Turner A, Dean OM, Kelly PJ, Arunogiri S, Koeijers J, Degan TJ, Degenhardt L, Farrell M, Goodman-Meza D, Sinclair B, Reid D, Cordaro F, Hill H, Lundin R, Hayllar J, Christmass M, Liaw W, Liu D, Woods A, Brewerton B, Holyoak E, Wu BT, Maher H, O'Dea N, Keygan J, Kontogiannis A, Palmer L, Morrison C, Wrobel A, Hyland B, Kiden G, Romeo V, Kyaw KWY, Byrne M, Colledge-Frisby S, Zahra E, Berk M.

2026-04-01

10.1001/jamapsychiatry.2026.0159

A phase 3 randomised double-blind placebo-controlled trial of mirtazapine as a pharmacotherapy for methamphetamine use disorder: a study protocol for the Tina Trial.

McKetin R, Degan TJ, Saunders L, Nguyen L, Dore G, Shoptaw S, Farrell M, Degenhardt L, Kelly PJ, Turner A, Clare PJ, Dean OM, Arunogiri S, Colledge-Frisby S, Koeijers J, Goodman-Meza D, Sinclair B, Reid D, Hill H, Hayllar J, Christmass M, Cordaro F, Lundin R, Liaw W, Liu D, Holyoak E, Wu BT, Keygan J, Kontogiannis A, Palmer L, Morrison C, Wrobel A, Hyland B, Byrne M, Russell S, Zahra E, Berk M.

2024-06-221 citations

10.1186/s13063-024-08238-y

Interventions

Oral mirtazapine tablets (30 mg) once per day for 12 weeks. Adherence will be monitored using MEMS® SmartCaps. Excipients consisting of: - Microcrystalline cellulose - Lactose monohydrate - Croscarmellose sodium - Magnesium stearate - Hypromellose - Hyprolose - Macrogol 8000 - Titanium dioxide - Iron oxide colouring

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

No

Inclusion criteria

• Aged between 18 and 65 years • Moderate to severe methamphetamine use disorder in the past year (DSM-5 past year diagnosis confirmed at Eligibility. Assessment using the Composite International Diagnostic Interview) • Current methamphetamine use (defined as using at least twice weekly in past 4 weeks based on the participant’s self-reported use, and a positive drug screening test for methamphetamine) • Willing to use effective contraception (for women only) • Willing to provide contact details for their treating physician • Willing to provide contact details for follow-up • Able to provide informed consent and able to comply with both the requirements of the informed consent and the treatment protocol Answer to query: The change in diagnostic criteria was made prior to any recruitment commencing. The change was made on protocol Version 5, dated 06/09/2022.

Exclusion criteria

• In need of acute care (e.g., suicidality or acute psychosis, unstable psychiatric condition; medical detoxification) • Pregnant or lactating • Incarceration or current inpatient treatment (including residential rehabilitation, inpatient detoxification); this applies to the status of the participant at trial enrolment and does not preclude the participant from entering treatment or receiving usual care during the trial • Contraindications for mirtazapine, including: o Known hypersensitivity to mirtazapine o Use of antidepressant medication (including monoamine oxidase inhibitors, St. John’s Wort, or SSRIs) other serotonergic drugs. • High risk of adverse reactions to mirtazapine including suicide, overdose, sudden cardiac death, risk of agranulocytosis, or accidents and injuries from motor impairment • Past year suicide attempt • Unable or unwilling to avoid pregnancy during the trial • Participation in another clinical trial

Outcome results