Opioid Use DisorderPhase 2NCT07128524
Ketones for Opioid Craving
A Phase 2 study testing Treatment with Ketone Supplement in people with Opioid Use Disorder, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Treatment with Ketone Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2026to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Caron Pennsylvania Addiction Treatment and Rehab Center
Wernersville, Pennsylvania, 19565
Erin Takemoto, PhD, 484-345-2626, etakemoto@caron.org
About this study
Official title: Ketone Supplementation for Opioid Craving and Withdrawal
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.
Read more
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
- Conditions
- Opioid Use Disorder
- Being tested
- Treatment with Ketone Supplement, Treatment with Placebo
- Keywords
- opioid use disorder, OUD, ketone, ketone supplement, ketone supplementation, craving, withdrawal
- Medical subject headings
- Opioid-Related Disorders, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with Ketone SupplementDietary supplement
Participants (n=25) will receive three doses of a ketone supplement drink daily for seven days.
Treatment with PlaceboDietary supplement
Participants (n=25) will receive three doses of a placebo drink for seven days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Ketone Supplement | Experimental | Participants (n=25) will receive three doses of a ketone supplement drink daily for seven days. Receives: Dietary Supplement: Treatment with Ketone Supplement |
| Treatment with Placebo | Experimental | Participants (n=25) will receive three doses of a placebo drink daily for seven days. Receives: Dietary Supplement: Treatment with Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Collected at baseline, and day 7
Secondary outcomes (6)
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.
Measured: Collected at baseline and days 1-7
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.
Measured: 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.
Measured: 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."
Measured: 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.
Measured: 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.
Measured: collected days 1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start16 Jul 2026
- Primary completion31 Aug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Caron Treatment Centers
- Responsible party
- Principal investigator, Peter Manza, University of Maryland, Baltimore
- Investigators
- Peter Manza, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128524
- Sponsor's protocol ID
- HP-00114810
- Status last verified
- Oct 2025
- First submitted
- 13 Aug 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketone Supplementation for Opioid Craving and Withdrawal
- ClinicalTrials.gov ID
- NCT07128524
- Acronym / sponsor ID
- HP-00114810
- Conditions
- Opioid Use Disorder
- Keywords
- opioid use disorder, OUD, ketone, ketone supplement, ketone supplementation, craving, withdrawal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Caron Treatment Centers
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with Ketone Supplement | Experimental | Dietary Supplement: Treatment with Ketone SupplementParticipants (n=25) will receive three doses of a ketone supplement drink daily for seven days. |
| Treatment with Placebo | Experimental | Dietary Supplement: Treatment with PlaceboParticipants (n=25) will receive three doses of a placebo drink daily for seven days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with Ketone SupplementParticipants (n=25) will receive three doses of a ketone supplement drink daily for seven days. | Dietary supplement | Treatment with Ketone Supplement |
| Treatment with PlaceboParticipants (n=25) will receive three doses of a placebo drink for seven days. | Dietary supplement | Treatment with Placebo |
Primary outcome
Tonic Craving (FORCAST) total scores
Time frame: 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
6 secondary outcomes
Subjective Opioid Withdrawal
Time frame: Collected at baseline and days 1-7
Pain Sensitivity (Cold Pressor Test)
Time frame: collected on day 1 and day 7
Desire for Drugs Questionnaire (DDQ)
Time frame: collected on days 1-7
Mood Ratings on a Visual Analogue Scale (VAS)
Time frame: collected on days 1-7
Chronic pain
Time frame: collected at baseline and day 7
Mood (Positive and Negative Affect Schedule)
Time frame: collected days 1-7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Manza, PhD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Treatment with Ketone Supplement in people with Opioid Use Disorder, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Manza, PhD (410-706-2814, peter.manza@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tonic Craving (FORCAST) total scores (time frame: Collected at baseline, and day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.