[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07128524":3,"trial-entities:NCT07128524":121,"trial-summary:NCT07128524":124},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":45,"secondary_outcomes":50,"sex":74,"minimum_age":75,"maximum_age":76,"healthy_volunteers":15,"eligibility_criteria":77,"std_ages":88,"locations":91,"central_contacts":107,"overall_officials":116,"references":119,"see_also_links":120},"NCT07128524","HP-00114810","Ketones for Opioid Craving","Ketone Supplementation for Opioid Craving and Withdrawal","RECRUITING","2027-09","2025-10","2026-08-25","2026-07-16","University of Maryland, Baltimore","OTHER",false,"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:\n\n* Does KS reduce craving for opioids in patients with opioid use disorder?\n* 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.\n\nParticipants will:\n\n* Be given KS or a placebo three (3) times daily for seven (7) days\n* Complete mood, pain tolerance, and subjective opioid withdrawal assessments",null,[19],"Opioid Use Disorder",[21,22,23,24,25,26,27],"opioid use disorder","OUD","ketone","ketone supplement","ketone supplementation","craving","withdrawal","INTERVENTIONAL","TREATMENT",[31],"PHASE2",{"count":33,"type":34},50,"ESTIMATED",[36,41],{"type":37,"name":38,"description":39,"armGroupLabels":40},"DIETARY_SUPPLEMENT","Treatment with Ketone Supplement","Participants (n=25) will receive three doses of a ketone supplement drink daily for seven days.",[38],{"type":37,"name":42,"description":43,"armGroupLabels":44},"Treatment with Placebo","Participants (n=25) will receive three doses of a placebo drink for seven days.",[42],[46],{"measure":47,"description":48,"timeFrame":49},"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",[51,55,59,63,66,70],{"measure":52,"description":53,"timeFrame":54},"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":56,"description":57,"timeFrame":58},"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",{"measure":60,"description":61,"timeFrame":62},"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",{"measure":64,"description":65,"timeFrame":62},"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\u002FSaddest, etc.\\] Ever' please indicate the point on the line that represents your current state.\"",{"measure":67,"description":68,"timeFrame":69},"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",{"measure":71,"description":72,"timeFrame":73},"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","ALL","18 Years","75 Years",{"inclusion":78,"exclusion":82,"raw_text":87},[79,80,81],"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",[83,84,85,86],"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","Inclusion Criteria:\n\n* Age 18-75 years\n* Meets currents DSM-5 criteria for OUD and admitted for opioid withdrawal management treatment at Caron Treatment Center\n* Willingness to provide signed, informed consent and commit to completing the procedures in the study\n\nExclusion Criteria:\n\n* 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).\n* 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\n* Currently pregnant or lactating, for people of childbearing potential\n* Judged by the principal investigator. study physician, or their designee to be an unsuitable candidate for the study",[89,90],"ADULT","OLDER_ADULT",[92],{"facility":93,"status":8,"city":94,"state":95,"zip":96,"country":97,"contacts":98,"geoPoint":104},"Caron Pennsylvania Addiction Treatment and Rehab Center","Wernersville","Pennsylvania","19565","United States",[99],{"name":100,"role":101,"phone":102,"email":103},"Erin Takemoto, PhD","CONTACT","484-345-2626","etakemoto@caron.org",{"lat":105,"lon":106},40.33009,-76.0805,[108,112],{"name":109,"role":101,"phone":110,"email":111},"Peter Manza, PhD","410-706-2814","peter.manza@som.umaryland.edu",{"name":113,"role":101,"phone":114,"email":115},"Kynah Walston, MA","443-974-7951","Kynah.Walston@som.umaryland.edu",[117],{"name":109,"affiliation":13,"role":118},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":122,"biomarkers":123},[19],[],{"nct_id":4,"found":125,"summary":126,"prompt_version":136},true,{"design":127,"status":128,"heading":129,"summary":130,"follow_up":131,"word_count":132,"commitments":133,"compensation":134,"drugs_mentioned":135},"This is an interventional study comparing a ketone supplement to a placebo in 50 participants. It is designed to see if the supplement can reduce opioid craving and withdrawal symptoms.","completed","Ketones for Opioid Craving Study","This study is looking at whether a ketone supplement can help reduce opioid cravings and withdrawal symptoms for adults with opioid use disorder (OUD) who are starting inpatient withdrawal treatment. Researchers will compare the ketone supplement to a placebo (an inactive drink) to see if it helps with cravings, low mood, and pain. You might be able to join if you are 18-75 years old, have OUD, and are admitted for opioid withdrawal management at Caron Treatment Center. The main goal is to see if the ketone supplement can lower your craving for opioids. The study is currently unclear about its status and plans to enroll 50 participants.","Your craving levels will be measured at the beginning of the study and again on day 7.",108,"You would receive either the ketone supplement or a placebo drink three times daily for seven days. You would also complete assessments for mood, pain tolerance, and opioid withdrawal.","Not stated in the trial record.",[],"v2"]