NCT04035200

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with alcohol use disorder (AUD) who experience insomnia associated with alcohol cessation, compared to placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 23, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2020

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

September 18, 2023

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

July 25, 2019

Results QC Date

July 27, 2023

Last Update Submit

September 14, 2023

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline of Wakefulness After Sleep Onset (WASO) Measured by Polysomnography (PSG)

    Wakefulness After Sleep Onset, as measured by PSG, was defined as wake time after persistent sleep (wake time during sleep plus wake time after sleep, expressed in minutes). Nights 1 / 2 is the average of the PSG measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the PSG measurements taken during nights 20 and 21 of study drug exposure.

    Baseline, Nights 1 / 2, Nights 20 / 21

Secondary Outcomes (16)

  • Change From Baseline in Mean Sleep Efficiency (SE)

    Baseline, Nights 1 / 2, Nights 20 / 21

  • Change From Baseline in Mean Latency to Persistent Sleep (LPS)

    Baseline, Nights 1 / 2, Nights 20 / 21

  • Change From Baseline in Mean Total Sleep Time (TST)

    Baseline, Nights 1 / 2, Nights 20 / 21

  • Change From Baseline in Mean Number of Awakenings (NAW)

    Baseline, Nights 1 / 2, Nights 20 / 21

  • Change From Baseline in Subjective Sleep Quality (sSleep)

    Baseline, Nights 1 / 2, Nights 20 / 21

  • +11 more secondary outcomes

Study Arms (3)

V117957 1 mg

EXPERIMENTAL

V117957 tablets taken orally at bedtime

Drug: V117957 tablets

V117957 2 mg

EXPERIMENTAL

V117957 tablets taken orally at bedtime

Drug: V117957 tablets

Placebo

PLACEBO COMPARATOR

Placebo to match V117957 tablets taken orally at bedtime

Drug: Placebo

Interventions

V117957 tabletsDRUG

V117957 tablets taken orally at bedtime

V117957 1 mgV117957 2 mg
PlaceboDRUG

Tablets to match V117957

Placebo

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female, 18-64 years of age with a body weight of 50-100 kg (110-220 lbs) and a body mass index (BMI) of 18-32 kg/m2.
  • Otherwise healthy as determined by medical evaluation that includes: medical history, physical examination, neurological exam, laboratory tests, vital signs, and cardiac monitoring.
  • History of moderate or severe alcohol use disorder (AUD) categorized based on Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria, as follows:
  • Moderate as defined by presence of 4-5 of the 11 criteria
  • Severe as defined by the presence of ≥ 6 of the 11 criteria.
  • At least 3 weeks and not more than 6 months since last alcoholic beverage intake at the time of study screening. Any subject who completed an alcohol detoxification program must be at least 7 days from completion of the program at the time of screening.
  • Persistent insomnia that emerged or worsened during AUD period, or during or after alcohol cessation characterized by a study-specific sleep diary.
  • A female participant is eligible to participate if she is not pregnant and not breastfeeding. Both females of childbearing potential and nonsurgically sterilized males with a sexual partner of childbearing potential must be willing to use adequate and reliable contraception throughout the study.
  • Willing to refrain from a behavioral or other treatment program for insomnia during participation in the study.

You may not qualify if:

  • Current diagnosis of a sleep-related breathing disorder including obstructive sleep apnea (with or without continuous positive airway pressure (CPAP) treatment), periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder or narcolepsy.
  • An apnea-hypopnea index (AHI) score of \>10 or a periodic limb movement arousal index (PLMAI) score of \> 15 recorded during the screening period PSG.
  • Documented history of insomnia prior to onset of the alcohol use disorder (AUD), which did not worsen during the AUD period or during or after alcohol cessation.
  • Comorbid conditions which interfere with normal sleep pattern or the evaluation of next day residual effects.
  • Any lifetime history of suicidal ideation or behavior.
  • History of or any current conditions that might interfere with drug absorption, distribution, metabolism, or excretion (including any surgical interventions for weight loss).
  • Any history of seizures (except related to alcohol withdrawal) or head trauma with sequelae.
  • Known history of testing positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV).
  • History of diagnosed, active liver disease or elevated liver enzymes/bilirubin.
  • History of kidney stones or renal insufficiency or abnormal kidney function at screening.
  • Uncontrolled hypertension (\> 140 mm Hg systolic / 90 mm Hg diastolic).
  • Use of any medication that affects sleep and/or wake function during the week before starting the screening period.
  • Subjects currently undergoing treatment of other addictions in addition to alcohol.
  • Excessive caffeine consumption.
  • Positive urine drug screen for prohibited substances, except for cannabis on a case-by-case basis.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

California Clinical Trials Medical Group

Glendale, California, 91206, United States

Location

Artemis Institute for Clinical Research

Riverside, California, 92503, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

CITrials

Santa Ana, California, 92705, United States

Location

SDS Clinical Trials, Inc.

Santa Ana, California, 92705, United States

Location

St. Francis Medical Institute

Clearwater, Florida, 33765, United States

Location

Research Centers of America

Hollywood, Florida, 33024, United States

Location

Research Centers of America, LLC

Miami, Florida, 33157, United States

Location

Innovative Clinical Research, Inc.

Miami Lakes, Florida, 33016, United States

Location

NeuroTrials Research Inc

Atlanta, Georgia, 30328, United States

Location

Investigational Site

Chevy Chase, Maryland, 20815, United States

Location

Sleep Disorders Centers of the Mid Atlantic

Glen Burnie, Maryland, 21061, United States

Location

Wake Research - Clinical Research Center of Nevada, LLC

Las Vegas, Nevada, 89104, United States

Location

SPRI Clinical Trials

Brooklyn, New York, 11235, United States

Location

Clinilabs Drug Development Corporation

New York, New York, 10019, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Advanced Medical Trials

Georgetown, Texas, 78628, United States

Location

Related Publications (1)

  • Whiteside GT, Kyle DJ, Kapil RP, Cipriano A, He E, Zhou M, Shet MS, Hummel M, Knappenberger T, Fukumura K, Matsuo Y, Uehira M, Hiroyama S, Takai N, Willsie SK, Harris SC. The nociceptin/orphanin FQ receptor partial agonist sunobinop promotes non-REM sleep in rodents and patients with insomnia. J Clin Invest. 2024 Jan 2;134(1):e171172. doi: 10.1172/JCI171172.

    PMID: 37883189DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Results Point of Contact

Title
Medical Information
Organization
Imbrium Therapeutics
Purduemedinfo@pharma.com
1-888-726-7535

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2019

First Posted

July 29, 2019

Study Start

September 23, 2019

Primary Completion

November 6, 2020

Study Completion

November 6, 2020

Last Updated

September 18, 2023

Results First Posted

September 18, 2023

Record last verified: 2023-09

Locations

US(17)