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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA022285 | U.S. NIH Grant/Contract | View source | |
| 1U54AA027989-01 | U.S. NIH Grant/Contract | View source | |
| 2U54AA027989 | U.S. NIH Grant/Contract | View source |
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On hold until new funding acquired.
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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For this protocol, the investigators plan to conduct a pilot study evaluating the effect of propranolol on alcohol consumption. Using a parallel design, the investigators plan to randomize 20 non-treatment seeking adults with alcohol use disorders (DSM-5) to propranolol extended release (160mg/day or placebo; n=10 per cell) to evaluate whether propranolol reduces alcohol self-administered in the laboratory. Importantly, the investigators will evaluate whether propranolol counteracts stress-induced effects on alcohol self-administration. Following titration to steady state medication levels over a 2-week period, each subject will complete two laboratory sessions consisting of a well validated method for inducing stress or neutral/relaxing state (order counterbalanced), followed by a 2-hour alcohol self-administration paradigm known to be sensitive to medication effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propranolol | Experimental | Propranolol extended release (160mg/day). Administered orally once daily at 10:00PM. Titration schedule Days 1-3 60mg, Days 4-7 80mg, Days 8-11 120mg, and Days 12-14 160mg until steady state. |
|
| Placebo | Placebo Comparator | Administered orally once daily at 10:00PM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propranolol | Drug | Propranolol Extended Release (160mg/day). |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol consumption | Mean mls of alcohol consumed (maximum of 120 mg/dL) for propranolol and placebo groups during 120 minute alcohol self administration sessions taking place as close to Day 15 and Day 19 as possible of medication dosing. | 120 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherry McKee, PhD | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06519 | United States |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Placebo |
| Drug |
Placebo pill administered orally. |
|
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |