Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
A legfontosabb adatok
- Ki végzi
- Ohio State University
- Hol
- Columbus (Egyesült Államok)A helyszín megnézése
- Azonosító
- Állapot
- Toborzás még nem indult
- Fázis
- Korai 1. fázis
- Résztvevők
- 90 fő, tervezett
- Kezdés
- 2026. nov.
- Várható befejezés
- 2028. aug.
- A vizsgálat típusa
- Beavatkozással járó, 3 csoport
- A vizsgált kezelések
- Alcohol
- Placebo
- A regiszteradat frissítve
- 2026. október 26.
Ki vehet részt
- Életkor
- 21 év – 65 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 27 feltétel megnézéseKevesebb
Ki vehet részt
- ALC Only Group:
- 21-65 years old
- Required to meet NIAAA criteria for heavy drinking (Male: Consuming 5 or more drinks on any day or 15 or more per week; Female: consuming 4 or more on any day or 8 or more drinks per week); OUD + ALC Group:
- 21-65 years old
- Required to meet NIAAA criteria for heavy drinking (Male: Consuming 5 or more drinks on any day or 15 or more per week; Female: consuming 4 or more on any day or 8 or more drinks per week)
- Meet DSM-5 criteria for current opioid use disorder (OUD)
- Report using recreational opioids at least weekly (past month); OUD-ALC Group:
- 21-65 years old
- Meet DSM-5 criteria for current OUD
- Report using recreational opioids at least weekly (past month)
- Meet "light drinking" criteria (consuming equal to or less than 4 drinks per week for women or consuming equal to or less than 5 drinks per week for men)
- Report at least 1 but no more than 3 binge episodes over the past 12 months
Ki nem vehet részt
- Current medical or psychiatric conditions requiring medication for which alcohol is contraindicated (including prescription opioids)
- Sensitivity or allergy to alcohol
- Moderate to severe substance use disorders other than alcohol use disorder (AUD) or OUD
- Current severe mental illness, including mania or psychosis
- Serious medical problems
- Any serious medical problems
- Body weight < 110 or > 210 lbs for alcohol administration
- Injury, trauma, nerve/tissue damage, or deformity prohibiting sensory testing
- Currently seeking inpatient/intensive treatment for addictive behaviors
- Pregnant or nursing and unwilling to take measures to avoid becoming pregnant during the study (females)
- Chronic pain requiring ongoing pain management within the past three months
- Clinically significant alcohol or opioid withdrawal symptoms the day of the lab sessions, defined as a score >10 on the Clinical Institute Withdrawal Assessment of Alcohol Scale Revised (CIWA-Ar) or a score >12 on the Clinical Opioid Withdrawal Scale (COWS)
- Positive alcohol breath test or opioid urine screen the day of the experimental lab sessions to avoid the potential for alcohol-opioid interactions
- Smoking more than 6 cigarettes per day (or alternative form equivalent)
- Not fluent in English
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 21 és 65 év között vagy?
Helyszínek itt: Egyesült Államok
- Ohio State UniversityColumbus, Egyesült ÁllamokContact: Stephanie Gorka, PhDToborzás még nem indult
A vizsgálatról
Mit akar kideríteni a vizsgálat
The goal of this clinical trial is to examine whether individuals with co-occurring opioid use disorder and alcohol use (OUD+ALC) experience heightened pain sensitivity, pain-related negative affect, and greater alcohol reinforcement compared with alcohol-only (ALC) or opioid-only (OUD-ALC) users.
A teljes eredeti leírásKevesebb
The main questions it aims to answer are:
* Aim 1. Do individuals with OUD+ALC experience increased pain and pain-related negative affect during periods of sobriety relative to mono-users of alcohol (ALC only) and opioids (OUD-ALC)? * Aim 2. Do individuals with OUD+ALC experience greater alcohol-induced analgesia and alcohol reinforcement compared with mono-users of alcohol (ALC only) and opioids (OUD-ALC)?
Participants will:
* Complete a screening session * Complete one lab session including a comprehensive assessment battery involving multimodal assessments of pain during sobriety * Complete two experimental lab sessions that will include intravenous (IV) administration of either 80mg% alcohol or placebo (saline), order counterbalanced, to measure alcohol's acute effects on pain and pain-related negative affect
A vizsgálat 3 csoportja
- Alcohol (ALC) Only GroupEgyéb csoport
Participants in this group will be required to meet the National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria for heavy drinking (Male: Consuming 5 or more drinks on any day or 15 or more per week; Female: consuming 4 or more on any day or 8 or more drinks per week).
Kezelés: Alcohol és Placebo
- Opioid Use Disorder (OUD) + ALC GroupEgyéb csoport
Participants in this group will be required to 1) Meet the National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria for heavy drinking (Male: Consuming 5 or more drinks on any day or 15 or more per week; Female: consuming 4 or more on any day or 8 or more drinks per week); 2) Meet DSM-5 criteria for current OUD and; 3) Report using recreational opioids at least weekly (past month).
Kezelés: Alcohol és Placebo
- OUD-ALC GroupEgyéb csoport
Participants in this group will be required to 1) Meet DSM-5 criteria for current OUD; 2) Report using recreational opioids at least weekly (past month); 3) Meet "light drinking" criteria (consuming less than or equal to 4 alcoholic drinks per week (female) or less than or equal to 5 alcoholic drinks (men) and; 4) Report at least 1 but no more than 3 binge episodes over the past 12 months.
Kezelés: Alcohol és Placebo
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Illeszkedési kérdések
- Forrás: NCT07894276: ki vehet részt
- A regiszteradat frissítve
- 2026. október 26.