女性のメタンフェタミン離脱のための鼻腔内オキシトシン (mOXY)
女性のメタンフェタミン離脱に対する鼻腔内オキシトシンの非盲検パイロット研究
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 the feasibility 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.
There is an observational sub-study affiliated with this main pilot study that is optional for individuals recruited to the main pilot trial to additionally participate in. This sub-study aims to investigate how sleep quality and patterns change before, during, and after detoxification from methamphetamine in women. MUD and sleep disturbances have a complex bidirectional relationship. The use of methamphetamine is known to disrupt sleep quality and the circadian rhythm, although withdrawal from methamphetamine also induces significant sleep-wake cycle changes. There is evidence that methamphetamine disrupts functions regulated by the circadian rhythm. Furthermore, disruptions in circadian rhythms, including mutations in key genes, increases the propensity for addiction. Evaluation of how chronic methamphetamine use may disrupt rhythmicity, and vice versa, may provide invaluable information with regard to potential treatment options of methamphetamine use disorder. There has been little focus, so far, on the therapeutic potential of circadian rhythm modifiers as treatment options in the addiction space, as sleep disturbances have often been merely viewed as a consequence of substance use.
Specific to the sub-study, participants will be asked to wear an actigraphy watch. The actigraphy watch device will be worn for at least 7 days prior to, 7 days during, and 7 days post methamphetamine detoxification. This is the only difference between the sub-study and the main pilot study; there are no other additional requirements or assessments involved in the actigraphy sub-study.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Victoria
-
Richmond、Victoria、オーストラリア、3121
- Turning Point
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adult females (sex assigned at birth) aged ≥18 to ≤65 years, admitted to the Turning Point Addiction Medicine Unit.
- Meeting DSM-5 criteria for Methamphetamine Use Disorder, moderate or severe (assessed by treating physician on pre-admission to residential withdrawal).
- Able to comply with study protocols.
- Able to provide informed consent to participate.
Exclusion Criteria:
- Non-English-speaking women.
- Women lactating, pregnant or of childbearing potential who are not willing to use an effective means of contraception for the duration of the trial.
- 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.
- 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.
- Current participation in another trial.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
Intranasal oxytocin, administered dose 24 international units (IU) twice daily, delivered over 7 days of a residential inpatient withdrawal admission. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility assessment
時間枠：Screening to Admission Day 1
|
Feasibility, operationalised as the proportion of all screened participants who were ineligible before enrolment, with ≤20% indicating feasibility. |
Screening to Admission Day 1
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Length of stay in the inpatient withdrawal unit
時間枠：Admission Day 1 to Admission Day 7
|
Medical chart review to determine number of days stayed in the inpatient withdrawal unit. |
Admission Day 1 to Admission Day 7
|
|
Methamphetamine withdrawal symptom severity
時間枠：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). |
Admission Day 1 to Admission Day 7
|
|
Methamphetamine craving
時間枠：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). |
Admission Day 1 to Admission Day 7
|
|
Sleep dysfunction
時間枠：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). |
Admission Day 1 to Admission Day 7
|
|
Mood disturbance
時間枠：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) |
Admission Day 1 to Admission Day 7
|
|
Methamphetamine relapse
時間枠：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. |
1-month post-discharge
|
|
Treatment engagement
時間枠：1-month post-discharge
|
Yes/No attendance at any form of treatment to assess treatment engagement at 1-month post-discharge. |
1-month post-discharge
|
|
Therapeutic alliance
時間枠：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). |
1-month post-discharge
|
|
Incidence of adverse events
時間枠：Day 1 of admission to 1-month post-discharge
|
Number and categorisation of reported adverse events. |
Day 1 of admission to 1-month post-discharge
|
|
Perceived burden of intranasal oxytocin
時間枠：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). |
Admission Day 1 to Admission Day 7
|
|
Perceived satisfaction with intranasal oxytocin
時間枠：Admission Day 3 and 7
|
Satisfaction with medication based on results from the Treatment Satisfaction Questionnaire (scores on this measure range from 0 to 100, with higher scores indicating greater satisfaction). |
Admission Day 3 and 7
|
|
Severity of Clinical Condition
時間枠：Baseline to 1-month post-discharge
|
Change in clinician-rated assessment of the participant's condition using the Clinical Global Impression - Severity Scale (scores on this measure range from 1 to 7, with higher scores indicating poorer condition). |
Baseline to 1-month post-discharge
|
|
Improvement of Clinical Condition
時間枠：1-month post-discharge
|
Clinician-rated assessment of the participant's overall clinical condition, substance use, and related problems compared to a baseline assessment, using the Clinical Global Impression - Improvement Scale (scores on this measure range from 5 to 35, with higher scores indicating a worsening of condition in comparison to baseline). |
1-month post-discharge
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in facial emotion recognition
時間枠：Baseline to 1-month post-discharge
|
Change in total score on the Facial Emotion Recognition Task at 1-month post-discharge compared to baseline. |
Baseline to 1-month post-discharge
|
|
Change in mentalisation
時間枠：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. |
Baseline to 1-month post-discharge
|
|
Change in social functioning
時間枠：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). |
Baseline to 1-month post-discharge
|
|
Sleep-wake cycles [part of the optional sub-study]
時間枠：7 days prior to, 7 days during, and 7 days post methamphetamine detoxification.
|
Change in sleep-wake cycles, as assessed via actigraphy monitoring, before, during and after methamphetamine detoxification. |
7 days prior to, 7 days during, and 7 days post methamphetamine detoxification.
|
|
Objective assessment of sleep quality [part of the optional sub-study]
時間枠：7 days prior to, 7 days during, and 7 days post methamphetamine detoxification.
|
Change in sleep quality, as assessed via actigraphy monitoring, before, during and after methamphetamine detoxification. |
7 days prior to, 7 days during, and 7 days post methamphetamine detoxification.
|
|
Objective assessment of sleep duration [part of the optional sub-study]
時間枠：7 days prior to, 7 days during, and 7 days post methamphetamine detoxification.
|
Change in sleep duration, as assessed via actigraphy monitoring, before, during and after methamphetamine detoxification. |
7 days prior to, 7 days during, and 7 days post methamphetamine detoxification.
|
|
Subjective sleep quality
時間枠：Baseline to 1-month post-discharge.
|
Change in score on the Pittsburgh Sleep Quality Index at 1-month post-discharge compared to baseline (scores on this measure range from 0 to 21, with higher scores indicating poorer sleep quality). |
Baseline to 1-month post-discharge.
|
|
Rhythmicity of sleep-wake cycles
時間枠：Baseline to 1-month post-discharge.
|
Sleep rhythmicity and categorisation of morning-evening preference grouping using the Morningness-Eveningness Questionnaire-Reduced Scale (scores on this measure range from 4-25, where higher scores are indicative of morning-type preferences - scores are categorised into one of 5 preference groups, ranging from "Definitely Evening Type" to "Definitely Morning Type"). |
Baseline to 1-month post-discharge.
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Shalini Arunogiri、Turning Point, Eastern Health, Monash University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- E21-014-75603
- NCR3SF18 (その他の助成金/資金番号：NCCRED)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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