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| Name | Class |
|---|---|
| Caron Treatment Centers | OTHER |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Ketone Supplement | Experimental | Participants (n=25) will receive three doses of a ketone supplement drink daily for seven days. |
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| Treatment with Placebo | Experimental | Participants (n=25) will receive three doses of a placebo drink daily for seven days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with Ketone Supplement | Dietary Supplement | Participants (n=25) will receive three doses of a ketone supplement drink daily for seven days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tonic Craving (FORCAST) total scores | 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 | Collected at baseline, and day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Opioid Withdrawal | Subjective Opioid Withdrawal Scale (SOWS): a 16-item patient self-report instrument to assess common subjective symptoms of craving and withdrawal. The SOWS uses a 0-4 scale for each item (0=not at all, 1=a little, 2=Moderately, 3=Quite a bit, 4=Extremely). Higher scores indicate higher levels of opioid withdrawal. Scores range from 0-64. | Collected at baseline and days 1-7 |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiome beta diversity | Stool samples will be collected and the beta diversity of the gut microbiome of the experimental (ketone supplement) group will be compared to the placebo group. | collected at baseline and day 7 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Manza, PhD | Contact | 410-706-2814 | peter.manza@som.umaryland.edu | |
| Kynah Walston, MA | Contact | 443-974-7951 | Kynah.Walston@som.umaryland.edu |
| Name | Affiliation | Role |
|---|---|---|
| Peter Manza, PhD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caron Pennsylvania Addiction Treatment and Rehab Center | Wernersville | Pennsylvania | 19565 | United States |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment with Placebo | Dietary Supplement | Participants (n=25) will receive three doses of a placebo drink for seven days. |
|
| Pain Sensitivity (Cold Pressor Test) | Cold Pressor Test is a well-validated measure of pain sensitivity that consistently elicits hyperalgesia in people with OUD, including those taking medications for OUD. Individuals will perform the test no later than the end of the first day of KS and again on the last day of KS. Participants plunge their dominant hand and forearm in an ice bath maintained at 5 degrees C. There are two outcomes associated with this test: pain threshold and pain tolerance. Pain threshold is the duration of time lapsed before the individual rates the sensation as painful. Pain tolerance is the duration of time the individuals keeps their arm immersed before it becomes subjectively unbearable (i.e., the individual removes their arm from the bath). Trials will be terminated if their arm is still submerged after five minutes, since pain responses on this task tend to peak by 90 seconds and diminish to below tolerance threshold within five minutes of immersion. | collected on day 1 and day 7 |
| Desire for Drugs Questionnaire (DDQ) | Desires for Drugs Questionnaire (DDQ): A 14-item assessment measured on a 7-point Likert scale with 0 representing "totally disagree" and 6 representing "totally agree" and is composed of three subscales: Desire and Intention, Negative Reinforcement, and Control. A higher score indicates a higher desire for the drug. | collected on days 1-7 |
| Mood Ratings on a Visual Analogue Scale (VAS) | A six-item validated visual analogue scale of self-report of mood. The six items represent the three primary factors of the Profile of Mood States (happy, sad, alert, tired, relaxed, nervous) Participants will see a horizontal line with 0 on the left end and 100 on the right end and will be asked "With zero (0) meaning 'Not [Happy, Sad, etc.] At All' and 100 meaning '[Happiest/Saddest, etc.] Ever' please indicate the point on the line that represents your current state." | collected on days 1-7 |
| Chronic pain | Graded Chronic Pain Scale (GCPS-R) is a 6-item instrument that evaluates chronic pains severity (intensity and impact on life activities). Graded scores range from 0-3 (0=Chronic Pain Absent, 1=Mild Chronic Pain, 2=Bothersome Chronic Pain, 3=High Impact Chronic Pain). Higher scores indicate higher impact of chronic pain. | collected at baseline and day 7 |
| Mood (Positive and Negative Affect Schedule) | Positive and Negative Affect Schedule (PANAS) is a 20 item Likert type instrument in which participants rate the extent to which they have felt specific emotions (both positive and negative) over the past week (or since they last completed the survey). The PANAS uses a 1-5 scale (1=very slightly or not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely) for each item, with higher scores indicating a higher extent that a participant has experienced a particular emotion. Scores range from 20-100. | collected days 1-7 |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |