Alcohol Drinking Clinical Trial
Official title:
A Post Marketing Study to Evaluate the Safety and Efficacy of Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use
Verified date | September 2022 |
Source | Endourage, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is the first clinical trial of Endourage OMD 1200 for persons desiring to reduce their alcohol consumption.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 31, 2022 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age 18 years of age or older who can provide informed consent 2. Ability to read and write in the English language and follow study-related procedures 3. Ability to have mail/ study drug delivered to an address and/or P.O. Box in the recipient's name. 4. If a woman of childbearing age, willing to use a dual method of contraception (barrier and/or hormonal) Exclusion Criteria: 1. Active illicit or non-prescribed drug use 2. Concomitant use of benzodiazepines 3. Concomitant use of Antabuse 4. Documented history and active treatment for seizure disorder 5. Transaminase elevation 6. Hepatitis C infection (currently on therapy and/or any transaminitis elevation) 7. Hepatitis B infection (currently on therapy and/or any transaminitis elevation) 8. Any form of mental impairment that will/could hinder safe participation in the study 9. Pregnancy or breast-feeding |
Country | Name | City | State |
---|---|---|---|
United States | Thomas P Young, PhD, NP | Novato | California |
Lead Sponsor | Collaborator |
---|---|
Endourage, LLC |
United States,
Everitt BJ, Robbins TW. Neural systems of reinforcement for drug addiction: from actions to habits to compulsion. Nat Neurosci. 2005 Nov;8(11):1481-9. Review. Erratum in: Nat Neurosci. 2006 Jul;9(7):979. — View Citation
Grotenhermen F. Pharmacokinetics and pharmacodynamics of cannabinoids. Clin Pharmacokinet. 2003;42(4):327-60. Review. — View Citation
Laviolette SR, Grace AA. The roles of cannabinoid and dopamine receptor systems in neural emotional learning circuits: implications for schizophrenia and addiction. Cell Mol Life Sci. 2006 Jul;63(14):1597-613. Review. — View Citation
MacCallum CA, Russo EB. Practical considerations in medical cannabis administration and dosing. Eur J Intern Med. 2018 Mar;49:12-19. doi: 10.1016/j.ejim.2018.01.004. Epub 2018 Jan 4. Review. — View Citation
Moreira FA, Lutz B. The endocannabinoid system: emotion, learning and addiction. Addict Biol. 2008 Jun;13(2):196-212. doi: 10.1111/j.1369-1600.2008.00104.x. Epub 2008 Apr 16. Review. — View Citation
Parsons LH, Hurd YL. Endocannabinoid signalling in reward and addiction. Nat Rev Neurosci. 2015 Oct;16(10):579-94. doi: 10.1038/nrn4004. Epub 2015 Sep 16. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anxiety scores | Generalized Anxiety Disorder (GAD-7), measure for anxiety. Baseline scores will be compared to scores at end of study across arms. Change in anxiety scores from baseline to end of study will be measured. Range from 0-4 for minimal; 5-9 mild; 10-14 moderate; 15-21 severe. Changes will be compared across arms. Increased scores will indicate that study product was not effective in decreasing symptoms measured (anxiety). | 112 days (4-months) | |
Primary | Depression scores | Patient Health Questionnaire (PHQ-9), measure for depression. Change in depression scores from baseline to end of study.
Total Score for Depression Severity will be compared across arms from baseline to end of study at 112-days. Score ranges from: 1-4 Minimal depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderately severe depression; 20-27 Severe depression. Increased scores indicate that study product is not effective in decreasing symptoms measured (depression). |
112 days (4-months) | |
Primary | Alcohol craving scores | The Alcohol Craving Questionnaire Short Form (ACQ-SF-R) will be compared from baseline to end of study.
Changes in craving score will be measured in each arm of study. Scores from 1-7 (strongly disagree to strongly agree) is measured across 12 items and 4 sub-scales ([1] compulsivity, [2] expectancy, [3] purposefulness, and [4] emotionality). The sum of the raw scores for each factor will be calculated and compared from baseline to the end of study across arms. Increased scores indicate that study product is not effective in reducing cravings for alcohol. |
112 days (4-months) | |
Secondary | To determine CBDs impact on anxiety, depression, and alcohol craving that trigger desires to consume alcohol versus abstain. | Daily diary of symptom(s), dose(s) of study product and alcohol use will be kept by participants.
Diary entries of symptoms, daily dose of study product and daily alcohol use will be measured and compared across study arms from baseline to end of study. |
112 days (4-months) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05414344 -
A Brief Intervention for Alcohol Users With Interpersonal Trauma
|
N/A | |
Completed |
NCT05521906 -
Evaluation of PRYSHM for LGBTQIA2S+ Youth
|
N/A | |
Not yet recruiting |
NCT04786587 -
Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
|
||
Not yet recruiting |
NCT03632408 -
Hangover and Residual Zopiclone Effect on Spatial Perception
|
Phase 1 | |
Completed |
NCT02718508 -
An e-Parenting Skills Intervention to Decrease Injured Adolescents' Alcohol Use
|
N/A | |
Active, not recruiting |
NCT02629679 -
Sports, Education and Consumption of Substances in Adolescents
|
N/A | |
Completed |
NCT02945371 -
Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life
|
N/A | |
Completed |
NCT01553136 -
Varenicline Treatment of Alcohol Dependence in Smokers
|
Phase 2 | |
Completed |
NCT01442753 -
Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth
|
N/A | |
Completed |
NCT01081119 -
Brief Voluntary Alcohol and Drug Intervention for Middle School Youth
|
Phase 2 | |
Completed |
NCT04510116 -
Adults In The Making Prevention Trial
|
N/A | |
Completed |
NCT00289965 -
Substance Use Risk Education (SURE) Project
|
Phase 2 | |
Completed |
NCT00506753 -
Motivation and Skills for Delta-9-tetrahydrocannabinol/Ethanol (THC/ETOH+) Teens in Jail
|
N/A | |
Recruiting |
NCT05288790 -
Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT
|
Phase 2 | |
Recruiting |
NCT05620849 -
Young Adult Education on Alcohol & Health
|
N/A | |
Recruiting |
NCT03588754 -
Does Propranolol, a Beta Blocker, Attenuate Stress-Induced Drinking?
|
Phase 2 | |
Recruiting |
NCT04054466 -
Nursing Counseling to the Change of Behavior of Alcohol Consumption in Patients in HAART
|
N/A | |
Recruiting |
NCT06074341 -
TeleHealth Resources for IndiVidualizEd Goals (THRIVE) in Alcohol Recovery Study
|
N/A | |
Terminated |
NCT04596267 -
Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers
|
Phase 1 | |
Completed |
NCT03488927 -
Development and Pilot Trial of an Intervention to Reduce Disclosure Recipients Negative Social Reactions and Victims Psychological Distress and Problem Drinking
|
N/A |