Ketone Supplementation for Opioid Craving and Withdrawal
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Tonic Craving (FORCAST) total scores
研究概览
简要总结
The goal of this clinical trial is to learn if ketone supplementation (KS) works to reduce craving for opioids for adults with opioid use disorder (OUD) undergoing in-patient acute withdrawal management. The main questions it aims to answer are:
- Does KS reduce craving for opioids in patients with opioid use disorder?
- Does KS reduce symptoms of opioid withdrawal such as low mood and pain? Researchers will compare KS to a placebo to see if KS works to reduce craving for opioids and reduce withdrawal symptoms in adults entering in-patient acute withdrawal management for opioid use disorder.
Participants will:
- Be given KS or a placebo three (3) times daily for seven (7) days
- Complete mood, pain tolerance, and subjective opioid withdrawal assessments
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Meets currents DSM-5 criteria for OUD and admitted for opioid withdrawal management treatment at Caron Treatment Center
- •Willingness to provide signed, informed consent and commit to completing the procedures in the study
排除标准
- •Current severe gastrointestinal (GI), liver, or other clinically significant physical disease that may interfere with the intake of the ketone supplement (e.g., sever inflammatory bowel disease, cirrhosis).
- •Currently taking (within the past two weeks) GLP-1 receptor agonist medications, e.g. semaglutide, which can interfere with the absorption of the ketone supplement
- •Currently pregnant or lactating, for people of childbearing potential
- •Judged by the principal investigator. study physician, or their designee to be an unsuitable candidate for the study
研究组 & 干预措施
Treatment with Placebo
Participants (n=25) will receive three doses of a placebo drink daily for seven days.
干预措施: Treatment with Placebo (Dietary Supplement)
Treatment with Ketone Supplement
Participants (n=25) will receive three doses of a ketone supplement drink daily for seven days.
干预措施: Treatment with Ketone Supplement (Dietary Supplement)
结局指标
主要结局
Tonic Craving (FORCAST) total scores
时间窗: Collected at baseline, and day 7
Faceted Opioid Research Craving Assessment for Substance use Treatment (FORCAST) (Opioid Craving): A 26-item assessment of tonic craving that the person reports having felt over the prior one or two weeks. Participants indicate how much they disagree or agree with each statement on a scale that ranges from 0-6, with 0 representing "strongly disagree", 3 representing "neither agree nor disagree", and 6 representing "strongly agree". Higher scores indicate higher levels of craving. The minimum score is 0, and the maximum scores for each of the subscales are as follows: Preoccupation: 24 Negative Reinforcement: 30 Positive Reinforcement: 24 Motivation: 30 Lack of control: 24 Uneasiness: 24 Maximum total score for all subscales = 156
次要结局
- Subjective Opioid Withdrawal(Collected at baseline and days 1-7)
- Pain Sensitivity (Cold Pressor Test)(collected on day 1 and day 7)
- Desire for Drugs Questionnaire (DDQ)(collected on days 1-7)
- Mood Ratings on a Visual Analogue Scale (VAS)(collected on days 1-7)
- Chronic pain(collected at baseline and day 7)
- Mood (Positive and Negative Affect Schedule)(collected days 1-7)
- Subjective Opioid Withdrawal(Collected at baseline and days 1-7)
- Pain Sensitivity (Cold Pressor Test)(collected on day 1 and day 7)
- Desire for Drugs Questionnaire (DDQ)(collected on days 1-7)
- Mood Ratings on a Visual Analogue Scale (VAS)(collected on days 1-7)
- Chronic pain(collected at baseline and day 7)
- Mood (Positive and Negative Affect Schedule)(collected days 1-7)
研究者
Peter Manza
Assistant Professor
University of Maryland, Baltimore