[Federal Register Volume 87, Number 96 (Wednesday, May 18, 2022)]
[Notices]
[Pages 30224-30225]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-10614]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Pharmacotherapy for 
Adults With Alcohol-Use Disorders in Outpatient Settings: Systematic 
Review Update

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for supplemental evidence and data submissions.

-----------------------------------------------------------------------

SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review on Pharmacotherapy 
for Adults with Alcohol-Use Disorders in Outpatient Settings: 
Systematic Review Update, which is currently being conducted by the 
AHRQ's Evidence-based Practice Centers (EPC) Program. Access to 
published and unpublished pertinent scientific information will improve 
the quality of this review.

DATES: Submission Deadline on or before June 17, 2022.

ADDRESSES: 
    Email submissions: [email protected].
    Print submissions:

Mailing Address: Center for Evidence and Practice Improvement, Agency 
for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 
Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice 
Improvement, Agency for Healthcare Research and Quality, ATTN: EPC 
SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD 
20857

FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496 
or Email: [email protected].

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Program to complete a review of the evidence for Pharmacotherapy for 
Adults with Alcohol-Use Disorders in Outpatient Settings: Systematic 
Review Update. AHRQ is conducting this systematic review pursuant to 
Section 902 of the Public Health Service Act, 42 U.S.C. 299a.
    The EPC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Pharmacotherapy for Adults with Alcohol-Use Disorders in 
Outpatient Settings: Systematic Review Update, including those that 
describe adverse events. The entire research protocol is available 
online at: https://effectivehealthcare.ahrq.gov/products/alcohol-misuse-drug-therapy/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Pharmacotherapy for Adults with Alcohol-Use 
Disorders in Outpatient Settings: Systematic Review Update helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this indication. In the list, please indicate whether 
results are available on ClinicalTrials.gov along with the 
ClinicalTrials.gov trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, a summary, including the following elements: Study 
number, study period, design, methodology, indication and diagnosis, 
proper use instructions, inclusion and exclusion criteria, primary and 
secondary outcomes, baseline characteristics, number of patients 
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, 
effectiveness/efficacy, and safety results.
    [ssquf] A list of ongoing studies that your organization has 
sponsored for this indication. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including a study number, the study period, 
design, methodology, indication and diagnosis, proper use instructions, 
inclusion and exclusion criteria, and primary and secondary outcomes.
    [ssquf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this indication and an index outlining the relevant information in each 
submitted file.
    Your contribution is very beneficial to the Program. Materials 
submitted must be publicly available or able to be made public. 
Materials that are considered confidential; marketing materials; study 
types not included in the review; or information on indications not 
included in the review cannot be used by the EPC Program. This is a 
voluntary request for information, and all costs for complying with 
this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program 
website and

[[Page 30225]]

available for public comment for a period of 4 weeks. If you would like 
to be notified when the draft is posted, please sign up for the email 
list at: https://www.effectivehealthcare.ahrq.gov/email-updates.
    The systematic review will answer the questions below. This 
information is provided as background and AHRQ is not requesting that 
the public provide answers to these questions.

Key Questions (KQ)

    KQ 1a: Which medications are efficacious for improving consumption 
outcomes for adults with alcohol-use disorders in outpatient settings?
    KQ 1b: How do medications for adults with alcohol-use disorders 
compare for improving consumption outcomes in outpatient settings?
    KQ 2a: Which medications are efficacious for improving health 
outcomes (including functioning and quality-of-life outcomes) for 
adults with alcohol-use disorders in outpatient settings?
    KQ 2b: How do medications for adults with alcohol-use disorders 
compare for improving health outcomes (including functioning and 
quality-of-life outcomes) in outpatient settings?
    KQ 3a: What adverse effects are associated with medications for 
adults with alcohol-use disorders in outpatient settings?
    KQ 3b: How do medications for adults with alcohol-use disorders 
compare for adverse effects in outpatient settings?
    KQ 4: Are medications for treating adults with alcohol-use 
disorders effective in primary care settings?
    KQ 5: Are any of the medications more or less effective than other 
medications for older adults, younger adults, smokers, or those with 
co-occurring disorders?

PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and 
Setting)

 Population(s)

    [cir] Adults (age 18 years or older) with alcohol-use disorders.

 Interventions

    [cir] Pharmacotherapy for relapse prevention. This includes:
    [ssquf] Medications approved by FDA for treating alcohol 
dependence:

     Acamprosate
     disulfiram
     naltrexone (oral or injectable)

    [ssquf] Certain medications in use off label that are available in 
the United States:
 Baclofen
 gabapentin
 ondansetron
 topiramate
 prazosin
 varenicline

    [cir] Studies evaluating pharmacotherapy that used co-interventions 
with other treatments for AUDs (e.g., behavioral counseling, cognitive 
behavioral therapy, motivational enhancement therapy, psychosocial 
treatments, or self-help such as 12-step programs [e.g., Alcoholics 
Anonymous]) will be eligible for inclusion, as long as they meet other 
inclusion/exclusion criteria.
    [cir] This review will not include pharmacotherapy for alcohol 
withdrawal.

 Comparators

    [cir] Studies must compare one of the medications listed above with 
placebo or another eligible medication.

 Outcomes

    [cir] Consumption outcomes:

[ssquf] Abstinence/any drinking
    --rates of continuous abstinence
    --percentage of days abstinent
    --time to first drink/lapse
    --time to heavy drinking/relapse
[ssquf] reduction in alcohol consumption
    --number of heavy drinking days
    --percentage of subjects with no heavy drinking days
    --number of drinking days
    --drinks per drinking day
    --drinks per week

    [cir] Health outcomes:

[ssquf] Accidents
[ssquf] injuries
[ssquf] quality of life
[ssquf] function
[ssquf] mortality
    [cir] Adverse effects of intervention(s):
[ssquf] Withdrawals due to adverse events
[ssquf] nausea/vomiting
[ssquf] diarrhea
[ssquf] anorexia
[ssquf] alpitations
[ssquf] headache
[ssquf] dizziness
[ssquf] cognitive dysfunction
[ssquf] taste abnormalities
[ssquf] paresthesias (numbness, tingling)
[ssquf] metabolic acidosis
[ssquf] glaucoma
[ssquf] vision changes
[ssquf] suicidal ideation
[ssquf] insomnia
[ssquf] anxiety
[ssquf] rash
[ssquf] tiredness
[ssquf] weakness
[ssquf] constipation

 Timing

    [cir] Studies with at least 12 weeks of planned pharmacologic 
treatment and followup from the time of medication initiation.

 Setting

    [cir] Outpatient healthcare settings; KQ 4 applies to primary care 
settings only (i.e., internal medicine, family medicine, obstetrics/
gynecology, or college and university health clinics).

    Dated: May 12, 2022.
Marquita Cullom,
Associate Director.
[FR Doc. 2022-10614 Filed 5-17-22; 8:45 am]
BILLING CODE 4160-90-P