mOXY: Intranasal Oxytocin for Methamphetamine Withdrawal in Women
Study Details
Study Description
Brief Summary
Methamphetamine use disorder (MUD) is a significant public health concern with burden to individuals, families and health systems estimated to cost over $5 billion annually in Australia. In 2016/17 there were 49,670 Australian treatment episodes for MUD, the first step of which typically involves inpatient withdrawal. Currently there are no approved medications to help manage methamphetamine withdrawal and consequently many people drop out of treatment prematurely, leaving them vulnerable to relapse.
Oxytocin is a candidate medication that has the potential to increase treatment retention, reduce withdrawal syndrome severity, increase post-withdrawal treatment engagement and reduce relapse rates.
The aim of this pilot study is to investigate whether intranasal oxytocin can improve withdrawal treatment outcomes in adult women with MUD. The study will examine usability and efficacy of intranasal oxytocin as a treatment for methamphetamine withdrawal in women. This will be explored by assessing length of stay in residential withdrawal, withdrawal symptom severity, post-discharge treatment engagement and relapse rates in a group of women who are prescribed intranasal oxytocin during their medically supervised methamphetamine withdrawal at a residential detoxification program. The safety of intranasal oxytocin will also be assessed. A secondary objective of the study is to conduct an exploratory analysis regarding participants' capacity to interact effectively with others, as well as changes in social networks and/or engagement with therapeutic services.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intranasal oxytocin Participants will receive oxytocin by intranasal spray under clinician supervision (1 insufflation equating to an active dose of 24 IU) twice daily (i.e., 48 IU per day), delivered over 7 days of a residential inpatient withdrawal admission. |
Drug: Oxytocin nasal spray
Intranasal oxytocin, administered dose 24 international units (IU) twice daily, delivered over 7 days of a residential inpatient withdrawal admission.
|
Outcome Measures
Primary Outcome Measures
- Length of stay in the inpatient withdrawal unit [Admission Day 1 to Admission Day 7]
Medical chart review to determine number of days stayed in the inpatient withdrawal unit.
Secondary Outcome Measures
- Methamphetamine withdrawal symptom severity [Admission Day 1 to Admission Day 7]
Individual average score across the participants' length of stay in the inpatient withdrawal unit on the Amphetamine Withdrawal Questionnaire (scores on this measure range from 0 to 40 with higher score indicating greater severity).
- Methamphetamine craving [Admission Day 1 to Admission Day 7]
Individual average score across the participants' length of stay in the inpatient withdrawal unit on the Visual Analogue Scale for Craving (scores on this measure range from 0 to 100, with higher scores indicating greater craving).
- Sleep dysfunction [Admission Day 1 to Admission Day 7]
Individual average score across the participants' length of stay in the inpatient withdrawal unit on the Insomnia Severity Index (scores on this measure range from 0 to 28, with higher scores indicating greater sleep dysfunction).
- Mood disturbance [Admission Day 1 to Admission Day 7]
Individual average score across the participants' length of stay in the inpatient withdrawal unit on the Abbreviated Profile of Mood States - Revised Version (total mood disturbance scores on this measure range from 0 to 116, with higher scores indicating greater disturbance)
- Methamphetamine relapse [1-month post-discharge]
Relapse is defined as a yes/no result for any methamphetamine use in the month following discharge from the withdrawal unit, as assessed using the Timeline Follow Back measure.
- Treatment engagement [1-month post-discharge]
Yes/No attendance at any form of treatment to assess treatment engagement at 1-month post-discharge.
- Therapeutic alliance [1-month post-discharge]
Working Alliance Inventory-Short Form Revised will be used to assess therapeutic alliance with nominated primary provider (scores on this measure range from 12 to 60, with higher scores indicating better therapeutic alliance).
- Incidence of adverse events [Day 1 of admission to 1-month post-discharge]
Number of participants with adverse events based on Systematic Assessment for Treatment Emergent Events.
- Perceived burden of intranasal oxytocin [Admission Day 1 to Admission Day 7]
Individual average score across the participants' length of stay in the inpatient withdrawal unit on the Visual Analogue Scale for Medication Utilisation Burden (scores on this measure range from 0 to 100, with higher scores indicating greater perceived burden).
Other Outcome Measures
- Change in facial emotion recognition [Baseline to 1-month post-discharge]
Change in total score on the Facial Emotion Recognition Task at 1-month post-discharge compared to baseline.
- Change in metallisation [Baseline to 1-month post-discharge]
Change in total score on the Reading the Eyes in the Mind Task at 1-month post-discharge compared to baseline.
- Change in social functioning [Baseline to 1-month post-discharge]
Change in score on the Social Functioning Scale at 1-month post-discharge compared to baseline (scores on this measure range from 0 to 24, with higher scores indicating poorer social functioning).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult females (aged ≥18 to ≤65 years), admitted to the Turning Point Addiction Medicine Unit.
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Meeting DSM-5 criteria for Methamphetamine Use Disorder, moderate or severe (assessed by treating physician on pre-admission to residential withdrawal).
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Able to comply with study protocols.
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Able to provide informed consent to participate.
Exclusion Criteria:
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Non-English-speaking women.
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Women lactating, pregnant or of childbearing potential who are not willing to use an effective means of contraception for the duration of the trial.
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Meeting DSM-5 criteria for moderate-severe substance use disorder other than methamphetamine, nicotine and cannabis, as assessed by treating physician on pre-admission to residential withdrawal.
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Clinically significant or unmanaged medical or psychiatric illness (e.g., renal insufficiency, cirrhosis, unstable hypertension, unstable diabetes mellitus, seizure disorder, history of DSM-5 psychotic or bipolar disorder, current severe major depression, current suicidal ideation), assessed by treating physician on pre-admission to residential withdrawal.
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Current participation in another trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Turning Point | Richmond | Victoria | Australia | 3121 |
Sponsors and Collaborators
- Turning Point
- National Centre for Clinical Research on Emerging Drugs (NCCRED)
- Eastern Health
- Monash University
Investigators
- Principal Investigator: Shalini Arunogiri, Turning Point, Eastern Health, Monash University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E21-014-75603
- NCR3SF18