Ketamine-assisted psychotherapy for methamphetamine use disorder

Phase 4

• Conditions: Addiction; Methamphetamine use disorder; Mental Health - Addiction

• Registration Number: ACTRN12624000895583
• Lead Sponsor: St Vincent's Hospital Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-22
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Adults presenting to outpatient drug treatment services seeking treatment for methamphetamine use disorder (MAUD) satisfying all of the following criteria:

Greater than or equal to 18 years of age

Able to provide informed consent

Willing and able to comply with all study requirements, as determined by the Principal Investigator

Meets DSM-5-TR diagnostic criteria for Current Stimulant Use Disorder – Amphetamine-Type Substance – as determined by the Principal Investigator and confirmed with Mini International Neuropsychiatric Interview (MINI)

Urine drug screen (UDS) point of care (POC) test positive for methamphetamine

Seeking treatment to cease or reduce methamphetamine use

If person of childbearing potential, willing to avoid pregnancy for study duration

Willing to register as a client of the St Vincent’s Hospital Sydney (SVHS) Stimulant Treatment Program (STP)

Exclusion Criteria

DSM-5-TR diagnosis of current or past use disorder for ketamine or ketamine analogues as assessed by Mini International Neuropsychiatric Interview (MINI)

Prescribed or non-prescribed use of ketamine in the previous four weeks

Currently enrolled in another treatment trial of MAUD or clinical trial, which is likely to affect safety, data quality or may interfere with participation in this study, as determined by the Principal Investigator

Currently pregnant or breastfeeding, or planning on becoming pregnant during the course of the study

DSM-5-TR diagnosis of current psychotic disorder as assessed by the Principal Investigator including review of MINI

Current acute suicidality defined as ‘high risk’ using the C-SSRS-6 screener or as determined by the Principal Investigator

DSM-5-TR diagnosis of bipolar disorder as assessed by the Principal Investigator including review of MINI

Current DSM-5-TR diagnosis with other substance use disorders, moderate or severe, except tobacco, caffeine, or cannabis as assessed by the Principal Investigator including review of MINI. Opioid use disorder permitted if stable on opioid agonist treatment; OAT) (i.e. no dose changes for six weeks if on oral OAT and maximum of one missed dose/week. At least three months with no missed doses if on long-acting injectable)

History of sensitivity to ketamine or any other components of this product

If prescribed antidepressants, the participant must have been on a stable dose for four or more weeks

Contraindications to ketamine according to Australian Product Information:

Severe cardiovascular disease

Heart failure

Severe or poorly controlled hypertension

Recent myocardial infarction

History of stroke

Cerebral Trauma

Intracerebral mass or haemorrhage

Any other medical or psychiatric condition which in the opinion of the Principal Investigator would make participation hazardous. In particular, caution if severe liver, kidney or bladder disease, and also caution if elevated cerebrospinal fluid pressure, increased intraocular pressure, acute intermittent porphyria, seizures, hyperthyroidism, pulmonary or upper respiratory infection, intracranial mass lesions, a presence of head injury, globe injuries, or hydrocephalus.

Likely or planned surgery, travel, incarceration or other engagement during the study that may interfere with study participation

Study & Design

• Study Type: Interventional
• Study Design: Not specified