Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder
Alcohol Use DisorderAlcoholismThe aim of this study is to determine if a single dose of psilocybin administered with motivational enhancement therapy (MET) can reduce heavy drinking in patients with an alcohol use disorder (AUD).
Ketamine for Combined Depression and Alcohol Use Disorder
DepressionAlcohol Use DisorderThe goal of this clinical trial is to investigate the effects of ketamine, in combination with standard inpatient addiction therapy, for adults with depression and alcohol use disorder. After screening and enrollment, participants will undergo baseline assessments of depression, measures of alcohol use and craving, as well as neurocognitive function. Participants will then be randomized to either ketamine (intervention) or midazolam (control). All participants will be admitted for standard inpatient addiction therapy while receiving ketamine or midazolam. Measures on safety, depression and alcohol use disorder will be repeatedly assessed during and after treatment. Final follow-up assessment is scheduled 6 months after baseline assessment.
A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder
Alcohol Use DisorderThe goal of this clinical study is to test the effectiveness of a supplemental fMRI neurofeedback and/or TMS intervention in individuals seeking treatment for Alcohol Use Disorder. After an initial visit, participants will come in once a week for four (4) weeks for an intervention session, which may or may not include TMS and MRI. Participants will be contacted for monthly follow-ups (remotely) for up to 12 months and will be asked to come in for two MRI follow-ups at 6 and 12 months.
Mobile Rewarding Activity Centered Treatment
Alcohol Use Disorder (AUD)Alcohol Use Disorder (AUD) is a highly prevalent and significant public health problem. Behavioral treatments based in the principles of social learning theory and cognitive behavior therapy have been developed and tested for AUD, yet effect sizes are relatively small and rates of relapse following treatment are high. Theoretically informed adjunctive interventions may help to enhance the effects of extant AUD treatments. In particular, evidence suggests that environments lacking in substance-free (SF) activities contribute to the development and maintenance of AUD and that the availability of rewarding SF activities may serve as viable alternatives to compete with alcohol use. Building on the advantages of accessibility and low-cost option afforded by the use of mobile technology, this proposal outlines a well-integrated research and training plan to investigate a mobile health intervention to increase engagement in rewarding SF activities among patients in AUD treatment. This proposed research aims to develop and evaluate a mobile phone ecological momentary assessment plus ecological momentary intervention (EMA+EMI; entitled: mobile - Rewarding Activity Centered Treatment (m-ReACT)) app to augment existing AUD treatment. The m-ReACT app will monitor self-reported rewarding SF activity engagement in real-time and deliver personalized feedback that encourages participants to engage in highly rewarding activities that are goal-oriented and support positive treatment outcomes. This proposed intervention will be developed in two phases. Phase 1 will develop the m-ReACT app and Phase 2 will evaluate its efficacy in randomized control pilot trial with a sample of 50 AUD patients who have recently initiated outpatient AUD treatment. Participants in the pilot RCT will be randomly assigned to either the m-ReACT condition or an active control condition. It is hypothesized that m-ReACT will result in increased rates of percent days of alcohol abstinence and increased reinforcement from SF activities.
Virtual Reality Exposure Therapy in the Treatment of Alcohol Use Disorder
Alcohol Use DisorderThis study aims to compare the efficacy of two types of interventions, which are acceptance and commitment therapy (ACT) as compared with virtual reality exposure therapy (VRET) for alleviating psychological dependence on alcohol and preventing relapse. It also assesses the changes of EEG in patients with alcohol use disorder after completion of the above related interventions. In this study 120 subjects with alcohol use disorder who have completed 2 weeks of in-patient detoxification will be randomized into three groups (VRET, ACT and treatment-as-usual control groups) and undergo respective interventions. Then assessment will be performed at four timelines (baseline, 4 weeks after baseline which is immediately after completion of intervention, 12 weeks after baseline, and 24 weeks after baseline assessment).
EMA_Normalization of Alcohol Drinking in Young Adults
Alcohol DrinkingThis proposed study aims to evaluate incentive strategies on compliance rate of EMA, assess young adults' exposure to alcohol marketing, and its effect on receptivity outcomes, belief in normalization of alcohol drinking and alcohol consumption. The objectives are: To compare the compliance rate of EMA between participants receiving one-off bonus and incremental incentive and receiving incremental incentive only. To assess the association between exposure to alcohol marketing and drinking normalization, in terms of perceived popularity (descriptive norm), perceived social approval (injunctive norm) and positive expectancy. To assess the association between exposure to alcohol marketing and alcohol consumption. To assess the association between exposure frequency and receptivity to alcohol marketing. To assess the association between receptivity to alcohol marketing and drinking normalization. To assess the association between receptivity to alcohol marketing and alcohol consumption. To explore factor structure of perceived popularity (descriptive norm), perceived social approval (injunctive norm) and positive expectancy. To analyse drinking normalization effect in mediating the association between exposure to alcohol marketing, and alcohol consumption, and between receptivity and alcohol consumption.
The Efficacy of Probiotics for the Treatment of Alcohol Use Disorder Among Adult Males
Alcohol Use DisorderThis three-armed, parallel-group, single-blind, multi-center randomized control trial (RCT) aims to evaluate the efficacy of probiotic supplement compared with that of acceptance and commitment therapy (ACT) in ameliorating alcohol craving and severity of alcohol use disorder (AUD) in patients diagnosed with AUD after 2 weeks of in-patient detoxification. In addition, this study also compares the efficacy of probiotic supplement and ACT to mitigate common comorbid of AUD (such as depression and anxiety symptoms); changes in event-related potential (ERP) on electroencephalogram (EEG) monitoring which indicate reduce alcohol craving; and depreciate the serum level of pro-inflammatory cytokines, such as interleukin-1β (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) indicating lowering of systemic inflammation. In phase I of the study, 120 patients diagnosed with AUD (using Diagnostic and Statistical Manual for Mental Disorders 5th Edition or DSM-5) and 120 healthy controls will be recruited. The measured outcomes to be compared between patients with AUD and healthy non-AUD controls include ERP on EEG monitoring, serum levels of pro-inflammatory cytokines (IL-1β, IL-6, and TNF-α), and the fecal microbiota content. Then, in phase II of the study, 120 AUD patients will be randomized into three groups of intervention in a 1:1:1 ratio (Lactobacillus sp. probiotic, ACT and placebo group; n = 40 per group). The participants in probiotic and placebo groups will then consumed the Lactobacillus sp. Probiotic and placebo 1 sachet once a day of probiotic and placebo, respectively for 12 weeks. While participants in ACT group will undergo training for ACT one session per week for 8 weeks. Outcome assessments will be performed across four time points, such as t0 = before intervention began, t1 = 8 weeks after intervention began, t2 = 12 weeks after intervention began, and t3 = 24 weeks after intervention began. The primary outcomes to be measured are the degree of alcohol craving, alcohol withdrawal, and severity of alcohol use disorder. While the secondary outcomes to be assessed are severity of comorbid depression and anxiety symptoms, serum levels of pro-inflammatory cytokines (IL-1β, IL-6, and TNF-α), changes in ERP on EEG monitoring, and fecal microbiota content.
MDMA-assisted Prolonged Exposure Therapy for Comorbid Alcohol Use Disorder and Post-traumatic Stress...
PTSDAlcohol Use Disorder3 moreTo explore the effectiveness of of MDMA-assisted prolonged exposure therapy in improving treatment outcomes for individuals with comorbid PTSD and alcohol use disorder in a double-blind randomised placebo-controlled trial.
Intranasal Insulin for Treatment of Alcohol Use Disorder
Alcohol Use DisorderThis is a randomized controlled trial (RCT), within-subject, crossover, double-blind, placebo-controlled in non-treatment-seeking individuals with Alcohol Use Disorder (AUD) (N=40, 50% female) randomized to IN insulin or placebo. In a bar laboratory setting, randomized participants will receive a single dose of IN insulin (80IU) or an IN matched placebo (0.9% Saline). Participants will undergo a cue-reactivity paradigm followed by an alcohol challenge that includes an alcohol drink designed to raise the breath alcohol content (BrAC) to 0.08g/dL.
EMPOWER AUD Pivotal Trial
AlcoholismAlcohol Abuse1 moreMulti-site, double-blinded, prospective, randomized, sham-controlled study