Trial Summary
What is the purpose of this trial?This trial tests if using low-intensity sound waves on the brain can help reduce cocaine cravings in people with Cocaine Use Disorder. The treatment targets a specific brain area involved in craving.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the idea that LIFU for Cocaine Use Disorder is an effective treatment?
The available research shows that Low-Intensity Focused Ultrasound (LIFU) is being explored as a potential treatment for substance use disorders, including cocaine use disorder. However, the research primarily focuses on its safety and feasibility rather than its effectiveness. In comparison, other treatments like acupuncture, medications, and brainwave therapy have been tested for cocaine use disorder, but none showed direct improvements in drug use outcomes. This suggests that while LIFU is a promising area of study, more research is needed to determine its effectiveness compared to other treatments.
12345What safety data exists for LIFU treatment for cocaine use disorder?
The provided research does not contain any safety data on Low-Intensity Focused Ultrasound (LIFU) treatment for cocaine use disorder. The articles focus on cocaine's pharmacology, adverse reactions, and related health issues, but do not mention LIFU or its safety.
46789Is Low-Intensity Focused Ultrasound a promising treatment for cocaine addiction?
Low-Intensity Focused Ultrasound (LIFU) is a promising treatment for cocaine addiction because it offers a new approach to addressing the brain's reward system, which is affected by cocaine use. Unlike traditional methods, LIFU could potentially help reduce cravings and improve treatment outcomes by targeting specific brain areas involved in addiction.
34101112Eligibility Criteria
This trial is for adults over 18 with a recent diagnosis of cocaine use disorder, who can lie still for imaging tests, have reliable transport, and stable housing. They must be able to avoid cocaine at certain times during the study and meet criteria for MRI scans.Inclusion Criteria
I can lie down for a long time for scans.
I am willing and able to follow the study's schedule and procedures.
I have a way to get to all my appointments during the study.
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Exclusion Criteria
Please contact PI or Study Coordinator for more details.
Participant Groups
The study is testing Low-Intensity Focused Ultrasound (LIFU) against a sham device to see if it reduces cravings in people with Cocaine Use Disorder by looking at brain activity and subjective craving levels after exposure to cocaine cues.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Low-Intensity Focused Ultrasound (LIFU)Experimental Treatment1 Intervention
All subjects to receive LIFU and Sham in a randomized order.
Group II: Sham LIFUPlacebo Group1 Intervention
All subjects to receive LIFU and Sham in a randomized order.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UVA Center for Leading Edge Addiction ResearchCharlottesville, VA
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Who Is Running the Clinical Trial?
University of VirginiaLead Sponsor
References
Low-intensity focused ultrasound targeting the nucleus accumbens as a potential treatment for substance use disorder: safety and feasibility clinical trial. [2023]While current treatments for substance use disorder (SUD) are beneficial, success rates remain low and treatment outcomes are complicated by co-occurring SUDs, many of which are without available medication treatments. Research involving neuromodulation for SUD has recently gained momentum. This study evaluated two doses (60 and 90 W) of Low Intensity Focused Ultrasound (LIFU), targeting the bilateral nucleus accumbens (NAc), in individuals with SUD.
The effect of auricular acupuncture on psychophysiological measures of cocaine craving. [2004]This study used a randomized pretest/posttest control group design to test the effectiveness of auricular acupuncture interventions in diminishing psychological and physiological changes associated with cocaine craving in 30 treatment-seeking cocaine-dependent patients. The experimental group received the real auricular acupuncture intervention, insertion of needles into ear point locations specifically targeted for drug withdrawal. The control group received sham or placebo auricular acupuncture, insertion of needles into ear point locations not targeted for any specific therapeutic benefit. Psychological (Cocaine Craving Questionnaire - Now) and physiological (skin conductance activity) changes associated with cocaine craving were measured. Results showed no differences between the control and the experimental group in diminishing psychological and physiological measures associated with craving. There were differences from pre- to posttest on measures of psychological but not physiological craving for the combined experimental and control groups.
Effectiveness of adjunct therapies in crack cocaine treatment. [2022]Although intensive outpatient therapy is recommended for treatment of cocaine, psychosocial characteristics associated with crack cocaine abuse are also implicated in attrition from outpatient programs. Acupuncture, medications, and brainwave therapy (biofeedback), have all been used to encourage treatment retention and drug use outcomes. The effectiveness of three adjunct therapies in improving retention and drug use outcomes in intensive outpatient cocaine treatment was tested in a primarily young, indigent African-American sample of crack cocaine users at a community hospital in a low-income, high drug use neighborhood in Houston. Subjects were assigned to receive either neurobehavioral treatment alone or neurobehavioral with one of three adjunct therapies. These included acupuncture, anticraving medication, or brainwave therapy. Comparative results indicated that dosage of any adjunct therapy was associated with days in treatment and standard treatment sessions attended, and that standard treatment sessions attended was associated with negative urinalysis results at follow-up. None of the adjunct therapies were directly associated with drug use outcomes.
Clinical pharmacology and toxicology of cocaine. [2019]Cocaine abuse has produced a major epidemic health problem in North America in the 1980s. The abuse of cocaine is maintained by the drug's effects on brain reward systems, mediated at least in part by its dopaminergic action. The patterns and consequences of use are best understood by considering the pharmacokinetics (rapid absorption and delivery to the brain, relatively short half-life) and the pharmacodynamics (intense central and peripheral neural stimulation). Cocaine is used therapeutically as a topical and local anaesthetic. Toxicity occurs primarily in cocaine abusers, but also occasionally after therapeutic dosing. Medical complications reflect primarily excessive central nervous system stimulation and excessive vasoconstriction, the latter resulting in severe hypertension and/or organ ischaemia with associated organ injury. Most deaths that result from medical complications of cocaine intoxication are sudden and occur before medical intervention is possible. Other complications of cocaine abuse with severe personal and social consequences include traumatic deaths and injuries, and reproductive disturbances, as well as transmission of infectious diseases, especially AIDS. Cocaine addiction is clearly a problem, although the number of addicts is unknown. Pharmacologic treatment of cocaine addiction has as yet been unsuccessful. Psychosocial approaches remain the mainstay of therapy.
Neurostimulation techniques in the treatment of cocaine dependence: A review of the literature. [2018]Cocaine use disorder is a very common condition that represents a substantial public health problem, and no effective pharmacological or psychological therapies have been identified to date. Urgent therapeutic alternatives are therefore needed such as neurostimulation techniques. The purpose of this review is to describe and discuss studies that have evaluated the safety and efficacy of these techniques for the treatment of cocaine dependence.
Comprehensive surgical management of cocaine-induced midline destructive lesions. [2022]This article presents a review of the literature and proposes a protocol for managing acute and chronic midfacial cocaine-induced injuries.
Factors associated with adverse reactions to cocaine among a sample of long-term, high-dose users in São Paulo, Brazil. [2019]This cross-sectional survey investigates the frequency of adverse cocaine reactions and associated factors among regular cocaine misusers. A sample of 332 cocaine misusers from a range of treatment and nontreatment settings in São Paulo, Brazil, were interviewed using a questionnaire that includes the Severity of Dependence Scale (SDS), the General Health Questionnaire (GHQ-28), the CAGE, and an eight-item questionnaire investigating the frequency of specific adverse cocaine reactions. The most commonly described reactions were hot flushes (84%), uncontrollable shaking (76%), and feeling ill (75%). The most severe symptoms and least common were convulsions or fits (18%) and passing out (21%). Frequency of adverse reactions to cocaine was positively associated with out-of-treatment status, severity of cocaine dependence, ever having injected cocaine, using tranquilisers with cocaine, and GHQ score. Adverse reactions to cocaine are common among regular cocaine users. Some of the adverse effects, especially those on the heart and central nervous system, are potentially fatal. Preventive strategies should be developed to reduce the risk of adverse cocaine reactions. The findings are discussed in relation to the type of interventions that might be developed and lines of future research.
Safety of nalmefene for the treatment of alcohol use disorder: an update. [2020]Introduction: Reduced drinking has been debated as a treatment goal for heavy drinking alcohol-dependent patients, in whom treatment based on abstinence is not always an option. Nalmefene was the first drug approved by the European Medicines Agency (2013) with the indication of reduced drinking in high drinking risk level alcohol-dependent patients. Six years after its introduction in Europe, data from clinical experience can be compared with those from preclinical studies and pivotal registration studies to evaluate what nalmefene has added to the treatment of AUD.Areas covered: Systematic review of efficacy and safety data of nalmefene use in humans from preclinical, phase III and phase IV studies, including systematic reviews, meta-analyses, cost-effectiveness analyses, and other secondary analyses.Expert opinion: Nalmefene introduces a paradigm change in the treatment of AUD that makes it appealing to patients that are reluctant to embrace abstinence, and facilitate patient-centered care in heavy users. However, information regarding safety data in special populations (e.g., patients with alcohol-related diseases, pregnancy, psychiatric disease), and direct comparisons with other potential drugs for alcohol reduction are further needed. Despite the promising role of nalmefene, there are still some factors that limit its wide prescription further than in specialized settings.
Considerations on the physiopathological mechanism of inner ear damage induced by intravenous cocaine abuse: cues from a case report. [2013]Aim of the following paper is to discuss about the possible etiopathogenetic mechanisms of inner ear damage induced by cocaine abuse. Unfortunately the data concerning this topic are very limited; the authors are then presenting a literature review, also discussing the clinical presentation and the possible therapeutical approach of a clinical case of bilateral sudden sensorineural hearing loss following i.v. injection of cocaine.
Efficacy of acupuncture for cocaine dependence: a systematic review & meta-analysis. [2019]: BACKGROUND: Acupuncture is a commonly used treatment option for the treatment of addictions such as alcohol, nicotine and drug dependence. We systematically reviewed and meta-analyzed the randomized controlled trials of acupuncture for the treatment of cocaine addiction. METHODS: Two reviewers independently searched 10 databases. Unpublished studies were sought using Clinicaltrials.gov, the UK National Research Register and contacting content experts. Eligible studies enrolled patients with the diagnosis of cocaine dependence of any duration or severity randomly allocated to either acupuncture or sham or other control. We excluded studies of acupuncture methods and trials enrolling patients with polysubstance use or dependence. We abstracted data on study methodology and outcomes. We pooled the studies providing biochemical confirmation of cocaine abstinence. RESULTS: Nine studies enrolling 1747 participants met inclusion criteria; 7 provided details for biochemical confirmation of cocaine abstinence. On average, trials lost 50% of enrolled participants (range 0-63%). The pooled odds ratio estimating the effect of acupuncture on cocaine abstinence at the last reported time-point was 0.76 (95% CI, 0.45 to 1.27, P = 0.30, I2 = 30%, Heterogeneity P = 0.19). CONCLUSION: This systematic review and meta-analysis does not support the use of acupuncture for the treatment of cocaine dependence. However, most trials were hampered by large loss to follow up and the strength of the inference is consequently weakened.
Treatment of cocaine and alcohol dependence with psychotherapy and disulfiram. [2019]To evaluate disulfiram and three forms of manual guided psychotherapy for individuals with cocaine dependence and concurrent alcohol abuse or dependence.
Memory-focused cognitive therapy for cocaine use disorder: Rationale, design and protocol for an external pilot randomised controlled trial. [2022]Cocaine use disorder (CUD) is a debilitating condition characterised by maladaptive cocaine-related memories and impaired cognitive and behavioural control. There are no evidence-supported pharmacotherapies and only weakly effective psychological interventions specific for CUD. Our novel Memory-focused Cognitive Therapy (MFCT) aims to modify cocaine-related memories to reduce craving and drug use.