Effect of Allopregnanolone on Stress-induced Craving
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Alcohol Use Disorder
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized, double blind, placebo controlledMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Health Services Research
Participation Requirements
- Age
- Between 21 years and 50 years
- Gender
- Both males and females
Description
This is a double-blind, placebo-controlled study that will randomize 60 heavy "at risk" drinkers to 2 groups: targeted dose of targeted dose of 100 nM of ALLO (N=30) or placebo (N=30). Participants will receive a continuous infusion of ALLO (or placebo) for 175 min. Sixty min. after the start of the...
This is a double-blind, placebo-controlled study that will randomize 60 heavy "at risk" drinkers to 2 groups: targeted dose of targeted dose of 100 nM of ALLO (N=30) or placebo (N=30). Participants will receive a continuous infusion of ALLO (or placebo) for 175 min. Sixty min. after the start of the infusion, when ALLO levels are relatively stable, the stress induction paradigm will be introduced. Participants will be presented with a stress cue and a neutral cue in random order. Stress and neutral cues will consist of personalized 5 min. scripts created prior to testing. Measures of stress-induced craving and stress-induced anxiety will be presented before the cue (pre), immediately following the cue (post) and 10 min after (recovery).The study outcomes will include measures of stress-induced craving and stress-induced anxiety as well as measures of subjective mood effects, cognitive performance, and motor coordination.
Tracking Information
- NCT #
- NCT04015869
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Investigators
- Principal Investigator: Elizabeth Ralevski, PhD Yale University