Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder

Browse trials for

• Opioid-Related Disorders 1,439
• Alcoholic Intoxication 91
• Pain 2,450

Keywords

• Intravenous alcohol administration
• Opioid Use Disorder

Opioid-Related Disorders

1,439 studies on the registry are indexed under Opioid-Related Disorders; 291 are open to participants now.

This study's planned enrollment of 90 is above the median of 62 across 1,145 interventional studies indexed under Opioid-Related Disorders.

Lead sponsor

Ohio State University is the lead sponsor of 661 studies on the registry; 148 are open to participants now.

Of its 66 completed or terminated interventional studies of FDA-regulated products, 49 (74%) have results posted.

Study arms

• Other
  Alcohol (ALC) Only Group

  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).

  Drug: Alcohol · Drug: Placebo

• Other
  Opioid Use Disorder (OUD) + ALC Group

  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).

  Drug: Alcohol · Drug: Placebo

• Other
  OUD-ALC Group

  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.

  Drug: Alcohol · Drug: Placebo

Interventions

• DrugAlcohol

  Participants will receive 80 mg% intravenous alcohol and saline.

• DrugPlacebo

  Participants receive placebo (saline) intravenously.

Primary outcomes

1. Pain intensity during the pressure task, measured using a visual analog scale (VAS)

   Pain intensity will be reported during the pressure task administered during each of the three laboratory sessions (Baseline, Placebo, and Alcohol). Participants will rate their perceived pain intensity using a numerical rating scale ranging from 0-100.

   Time frame: Baseline (Visit 1), approximately 7 days later (Visit 2), and approximately 14 days after baseline (Visit 3)

2. Pain pressure threshold during the pressure task

   Pain pressure threshold is estimated by averaging reports across the different runs of the pressure task that is administered at all three lab sessions.

   Time frame: Baseline (Visit 1), approximately 7 days later (Visit 2), and approximately 14 days after baseline (Visit 3)

3. Startle eyeblink potentiation during the anticipation task

   Startle eyeblink potentiation will be collected during the anticipation task that is administered at all three lab sessions. Startle is a cross-species index of aversive reactivity.

   Time frame: Baseline (Visit 1), approximately 7 days later (Visit 2), and approximately 14 days after baseline (Visit 3)

4. Self-reported affect during the anticipation task

   At the end of the anticipation task, participants will rate how intense, arousing, and anxiety-provoking the task was on a 1-to-10 scale, with 1 indicating low intensity, arousal, or anxiety and 10 indicating high intensity, arousal, or anxiety.

   Time frame: Baseline (Visit 1), approximately 7 days later (Visit 2), and approximately 14 days after baseline (Visit 3)

5. Subjective affective response to alcohol in the lab

   Participants will complete the Profile of Mood States (POMS) throughout the placebo and alcohol administration protocols. The individual mood states will be examined and compared across sessions. Higher scores on each POMS subscale indicate a greater degree of the corresponding mood state, while lower scores indicate a lesser degree of that mood state.

   Time frame: Placebo and Alcohol sessions (Visits 2 and 3), approximately 7 days apart.

Secondary outcomes

1. Subjective effects of alcohol in the lab

   Participants will rate the degree to which they "feel", "like", and "want more" of the infused substance on a visual analog scale ranging from 0 to 100. The "like" and "want more" scales will serve as the primary measures of alcohol liking and wanting, respectively.

   Time frame: Placebo and Alcohol sessions (Visits 2 and 3), approximately 7 days apart.

Individual participant data

Plan to share: Yes — De-identified data, including startle eyeblink and behavior, from this project will be submitted to the The National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA) at the subject level along with appropriate supporting documentation to enable efficient use of the data by the research community. We will follow instructions as discussed in the NDA Data Sharing Terms and Conditions.

Time frame: The data will be submitted biannually.

Data sharing details ↗ · nda.nih.gov