Ignite Creation Date:
2024-05-06 @ 8:16 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02707055
Status:
TERMINATED
Last Update Posted:
2022-03-16
First Post:
2016-03-11
Brief Title:
A Novel Compound for Alcoholism Treatment A Translational Strategy - Part II
Sponsor:
National Institute on Alcohol Abuse and Alcoholism NIAAA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Novel Compound for Alcoholism Treatment A Translational Strategy - Part II
Status:
TERMINATED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Early termination of the study due to the COVID-19 pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Hormones are naturally occurring chemicals in the body Ghrelin is a hormone that stimulates appetite It may also stimulate alcohol cravings and use Researchers want to learn more about alcohol cravings and test if a drug that blocks ghrelin lowers alcohol cravings
Objective
To test if the drug PF-05190457 decreases alcohol craving
Eligibility
People ages 18-70 who have
Alcohol use disorder
No other serious medical problems
Woman must be postmenopausal or have had surgery to prevent pregnancy
Design
Participants will stay on the inpatient unit here at the Clinical Center for two 2-week stages which will be separated by at least 2 days The inpatient phase include
Taking the study drug or placebo by mouth twice daily
Blood tests
Tasting several sweet solutions
Physical exams
Exposure to alcohol water and food cues in a bar-like room Participants answer questions on a computer
Blood pressure and heart rate are monitored through an arm cuff and sensors on the chest
MRIs Participants lie on a table that slides in and out of the cylinder and a coil is placed over the head
They complete tasks on a computer screen while in the cylinder This lasts up to 2 hours
Wearing a virtual reality headset walking around a virtual room and selecting virtual food and drink
Physical exams
Hormones are naturally occurring chemicals in the body Ghrelin is a hormone that stimulates appetite It may also stimulate alcohol cravings and use Researchers want to learn more about alcohol cravings and test if a drug that blocks ghrelin lowers alcohol cravings
Objective
To test if the drug PF-05190457 decreases alcohol craving
Eligibility
People ages 18-70 who have
Alcohol use disorder
No other serious medical problems
Woman must be postmenopausal or have had surgery to prevent pregnancy
Design
Participants will stay on the inpatient unit here at the Clinical Center for two 2-week stages which will be separated by at least 2 days The inpatient phase include
Taking the study drug or placebo by mouth twice daily
Blood tests
Tasting several sweet solutions
Physical exams
Exposure to alcohol water and food cues in a bar-like room Participants answer questions on a computer
Blood pressure and heart rate are monitored through an arm cuff and sensors on the chest
MRIs Participants lie on a table that slides in and out of the cylinder and a coil is placed over the head
They complete tasks on a computer screen while in the cylinder This lasts up to 2 hours
Wearing a virtual reality headset walking around a virtual room and selecting virtual food and drink
Physical exams
Detailed Description:
Objective
Ghrelin is a 28-amino acid peptide that stimulates appetite and food intake It is an endogenous ligand for the growth hormone secretagogue receptor GHSR1a Preclinical studies suggest that ghrelin modulates alcohol reward processing Previous work from our research team indicated that intravenous IV ghrelin administration compared to placebo results in an acute increase in alcohol craving during a cue-reactivity experiment in alcoholic individuals Therefore an oral bioavailable ghrelin receptor antagonist that is able to pass through the blood brain barrier holds particular promise as a treatment for alcohol use disorder AUD This protocol is part of a grant project funded by National Center for Advancing Translational Sciences NCATS aimed to generate preliminary evidence in AUD on the safety and efficacy of a ghrelin receptor GHSR1a antagonist PF-05190457 an existing molecule available under the NIH-Industry Pilot Program at NCATS Completed preclinical and clinical Protocol 14-AA-0042 work has demonstrated the safety of PF-05190457alcohol interaction The goal of this protocol is to conduct a proof-of-concept human laboratory study to assess an early-signal of efficacy of PF-05190457 in AUD
Study population
The study population will be AUD individuals n 55
Study Design
A within-subject counterbalanced double-blind placebo-controlled study
Outcome measures
The primary aim will be to determine whether PF-05190457 compared to placebo reduces alcohol cue-elicited craving As another outcome will be to determine whether PF-05190457 compared to placebo reduces brain blood oxygen level dependent BOLD response during exposure to alcohol cues during a task-based fMRI scan We will also investigate the effects of PF-05190457 on food craving as well as on food choices using a virtual buffet experimental procedure All these outcomes will be assessed in the inpatient Unit at the NIH Clinical Center CC After the inpatient portion of the protocol patients will be followed-up as outpatients During the outpatient phase patients will be offered motivational interviewing and video feedback to explore the effects of this intervention compared to supportive counseling on maintaining motivation for alcohol abstinence and inform future studies where medications like PF-05190457 and behavioral treatments may be combined The outpatient phase is optional for treatment seeking and nontreatment seeking participants
Ghrelin is a 28-amino acid peptide that stimulates appetite and food intake It is an endogenous ligand for the growth hormone secretagogue receptor GHSR1a Preclinical studies suggest that ghrelin modulates alcohol reward processing Previous work from our research team indicated that intravenous IV ghrelin administration compared to placebo results in an acute increase in alcohol craving during a cue-reactivity experiment in alcoholic individuals Therefore an oral bioavailable ghrelin receptor antagonist that is able to pass through the blood brain barrier holds particular promise as a treatment for alcohol use disorder AUD This protocol is part of a grant project funded by National Center for Advancing Translational Sciences NCATS aimed to generate preliminary evidence in AUD on the safety and efficacy of a ghrelin receptor GHSR1a antagonist PF-05190457 an existing molecule available under the NIH-Industry Pilot Program at NCATS Completed preclinical and clinical Protocol 14-AA-0042 work has demonstrated the safety of PF-05190457alcohol interaction The goal of this protocol is to conduct a proof-of-concept human laboratory study to assess an early-signal of efficacy of PF-05190457 in AUD
Study population
The study population will be AUD individuals n 55
Study Design
A within-subject counterbalanced double-blind placebo-controlled study
Outcome measures
The primary aim will be to determine whether PF-05190457 compared to placebo reduces alcohol cue-elicited craving As another outcome will be to determine whether PF-05190457 compared to placebo reduces brain blood oxygen level dependent BOLD response during exposure to alcohol cues during a task-based fMRI scan We will also investigate the effects of PF-05190457 on food craving as well as on food choices using a virtual buffet experimental procedure All these outcomes will be assessed in the inpatient Unit at the NIH Clinical Center CC After the inpatient portion of the protocol patients will be followed-up as outpatients During the outpatient phase patients will be offered motivational interviewing and video feedback to explore the effects of this intervention compared to supportive counseling on maintaining motivation for alcohol abstinence and inform future studies where medications like PF-05190457 and behavioral treatments may be combined The outpatient phase is optional for treatment seeking and nontreatment seeking participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 16-DA-0080 | None | None | None |