Ketones for Opioid Craving

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Maryland, Baltimore

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Treatment with Ketone Supplement

    Dietary supplement

    Participants (n=25) will receive three doses of a ketone supplement drink daily for seven days.

  • Treatment with Placebo

    Dietary supplement

    Participants (n=25) will receive three doses of a placebo drink for seven days.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Treatment with Ketone SupplementExperimental treatment 1 intervention
Group B: Treatment with PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Collected at baseline, and day 7

Secondary outcomes

1

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.

Time frame
Collected at baseline and days 1-7
2

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.

Time frame
collected on day 1 and day 7
3

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.

Time frame
collected on days 1-7
4

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."

Time frame
collected on days 1-7

Other outcomes

1

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.

Time frame
collected at baseline and day 7

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland, Baltimore

Lead sponsor

Caron Treatment Centers

Collaborator