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Cocaine Use clinical trials

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NCT ID: NCT06177860 Recruiting - Clinical trials for Myocardial Infarction

Clinical and Atherosclerotic Characteristics of Patients With ACS Associated With Cocaine Use

Start date: November 17, 2023
Phase:
Study type: Observational

Cocaine use has increased in our country in recent decades. It is associated with cardiovascular events and early atherosclerotic disease. Acute coronary syndrome (ACS) is one of its most frequent and serious manifestations. There is a lack of scientific information on ACS associated with acute and chronic cocaine use in Argentina. This study aims to describe the socioeconomic, clinical, and coronary angiographic characteristics, as well as the extent of atherosclerotic disease in patients with ACS associated with cocaine use, and to compare them with ACS not associated with cocaine use. Methods: We propose an observational, analytical, single-center, two-phase study, with a retrospective and a prospective component. Patients with a diagnosis of ACS admitted to the coronary care unit of a high-complexity public hospital will be included. Clinical, biochemical, coronary angiographic, extracoronary atherosclerotic disease extension and prognostic variables will be described. These variables will be compared between patients with cocaine-associated ACS and non-cocaine-associated ACS.

NCT ID: NCT06045793 Not yet recruiting - Cocaine Abuse Clinical Trials

Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST)

CATALYST
Start date: December 11, 2023
Phase: Phase 2
Study type: Interventional

This is a Phase 2 single-blind, randomized, multicenter study to compare the efficacy and safety of a single dose of TNX-1300 to placebo with usual care in patients with acute cocaine intoxication within the emergency department setting.

NCT ID: NCT05974202 Not yet recruiting - Cocaine Dependence Clinical Trials

rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder

Start date: June 15, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to compare the effects of active repetitive transcranial magnetic stimulation (rTMS) to sham (placebo) rTMS prior to cognitive-behavioral therapy (CBT) as a treatment for adults with cocaine use disorder. The main questions it aims to answer are: - Is rTMS safe and feasible as an augmentation for CBT for the treatment of cocaine use disorder? - What is the brain mechanism of rTMS? - Will active rTMS (compared to sham rTMS) followed by CBT help adults with cocaine use disorder achieve abstinence from cocaine? Participants will: - Have two brain MRI scans; - Undergo 3 weeks of daily rTMS (or sham) treatments (15 sessions), and; - Have 12 weeks of once-weekly cognitive-behavioral therapy for the treatment of cocaine use disorder. Researchers will compare active (real) rTMS to sham (placebo) rTMS. All participants will receive cognitive-behavioral therapy.

NCT ID: NCT05824221 Not yet recruiting - Cocaine Dependence Clinical Trials

Effect of rTMS on Neurotrophines Levels in CUD

BDNFcoca
Start date: April 30, 2023
Phase: N/A
Study type: Interventional

Brief Summary: Background: Cocaine use disorders (CUD) is a multifactoral disease, involving several brain areas. One of the most investigated is the Dorsolateral Prefrontal Cortex (DLPFC) involved in impulsiveness control. Effective treatments for CUD are still needed and repetitive Transcranial Magnetic Stimulation (rTMS) is widely studied for its potential in reducing cocaine craving and consumption. Objectives: The main outcome is to test if rTMS can be related to neuroplasticity and neurotrophism through changes in Brain-Derived Neurotrophic Factor (BDNF) and its precursor (pro-BDNF) levels. Eligibility: Healthy, right-handed adults ages 18-65 who do have cocaine use disorder (moderate to severe). Design: This is a randomized, sham-controlled study. The study includes a rTMS continued treatment phase compared to healthy control (HC) evaluation. Prior to participating, participants will be screened with: - Medical history - Anamnestic sheet - Physical exam - Urine tests After being enrolled, participants and HC will undergo venous blood sample (BDNF and proBDNF levels). During the continued rTMS phase, participants with cocaine use disorder will be randomized to receive real or sham rTMS; a former arm is also provided and is made up of HC. RTMS will be delivered in 10 days, over 2 weeks (5 days/week). After the last rTMS session a blood sample for neurotrophines levels will be collected. Treatment includes: - rTMS: A coil is placed on the head. At each session, participants will receive two rTMS sessions, with a 50 mins interval. At the beginning of each rTMS session, they view cocaine-related images for few minutes (cue-induced stimuli). - BDNF/proBDNF levels: A venous blood sample will be collected before the first stimulation and after the last stimulation of the intensive-stimulation period (first two weeks), this sample will be also collected from HC. The blood sample will be centrifuged within 20 minutes of sampling at 1000 × g for 15 minutes. Then, the serum will be aliquoted and stored at -80 ° C until analysis. - Urine toxicological screen

NCT ID: NCT05809453 Recruiting - Exercise Clinical Trials

Intranasal Cocaine and Temperature Regulation During Exercise

Start date: September 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Assess the effects of intranasal cocaine on temperature regulation and whole-body sweat rate during exercise in warm environmental conditions.

NCT ID: NCT05766631 Recruiting - Opioid Use Clinical Trials

Treating Polysubstance Use Using a Novel Digital Technology

POLY
Start date: July 26, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to determine the effects of an app to reduce opioid and cocaine use when layered atop methadone treatment as usual among people using both opioids and cocaine. The main questions it aims to answer are: - Do people who use the app remain in methadone treatment longer than people who receive only treatment as usual? - Do people who use the app report using opioids and/or cocaine less often, and do they report better improvements in their quality of life, than people who receive only treatment as usual? - Does using the app more lead to better methadone treatment outcomes among people using the app? Participants in this study will be randomly assigned to receive either the app or methadone treatment as usual. Participants randomly assigned to the treatment as usual group will receive access to methadone services as normally provided, including scheduled access to medications, information about the consequences of opioid and other drug use, and any onsite services (including group based interventions and/or 12-step programs). Those randomized into the app-using group will receive all the same services as the treatment as usual group, but will also be given a phone with the app already installed, or will have the app installed on their existing phone if they already have one. At random times throughout the week, the app will ask participants to submit drug tests for opioids and cocaine, which participants will be able to do remotely without having to physically "go to" a testing site. For each test that demonstrates the participant hasn't used opioids or cocaine, the participant will be rewarded with money directly into a debit card. Participants will also be able to earn rewards for picking up treatment-related medications, attending onsite appointments, and other treatment-related activities.

NCT ID: NCT05704764 Enrolling by invitation - HIV Clinical Trials

Using the Ending Self-Stigma Intervention to Reduce Internalized Stigma Among People Living With HIV Who Use Substances

IRIS
Start date: February 17, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test an intervention to reduce stigma among people living with HIV who use opioids and cocaine. The main question it aims to answer is: - Does reducing internalized stigma about HIV and/or drug use lead to improved HIV care outcomes? After a year spent adapting an existing intervention to be applied specifically among people living with HIV who use substances, 70 participants will be randomized to receive either treatment-as-usual or the newly adapted intervention. The intervention itself will consist of less than ten group-based meetings to discuss and work through the stigmas people commonly associate with HIV and/or drug use.

NCT ID: NCT04927143 Recruiting - Opioid Use Clinical Trials

Encouraging Abstinence Behavior in a Drug Epidemic

Start date: September 15, 2021
Phase: Phase 2
Study type: Interventional

Combatting the rise of the opioid epidemic is a central challenge of U.S. health care policy. A promising approach for improving welfare and decreasing medical costs of people with substance abuse disorders is offering incentive payments for healthy behaviors. This approach, broadly known as "contingency management" in the medical literature, has repeatedly shown to be effective in treating substance abuse. However, the use of incentives by treatment facilities remains extremely low. Furthermore, it is not well understood how to design optimal incentives to treat opioid abuse. This project will conduct a randomized evaluation of two types of dynamically adjusting incentive schedules for people with opioid use disorders or cocaine use disorders: "escalating" schedules where incentive amounts increase with success to increase incentive power, and "de-escalating" schedules where incentive amounts decrease with success to improve incentive targeting. Both schemes are implemented with a novel "turnkey" mobile application, making them uniquely low-cost, low-hassle, and scalable. Effects will be measured on abstinence outcomes, including longest duration of abstinence and the percentage of negative drug tests. In combination with survey data, variation from the experiment will shed light on the barriers to abstinence more broadly and inform the understanding of optimal incentive design.

NCT ID: NCT04418076 Completed - HIV/AIDS Clinical Trials

Project SMART Automated Pillbox Study

SMART
Start date: June 8, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to examine the effect of mHealth tools on antiretroviral (ART) adherence and persistence among HIV-infected individuals with co-occurring cocaine use disorders (CUDs).

NCT ID: NCT04061941 Recruiting - Substance Use Clinical Trials

Change in Cognitive Function in Stimulant Users

SToP-S_CogFx
Start date: October 21, 2019
Phase:
Study type: Observational

In Hong Kong, methamphetamine use is common and cocaine use has increased steadily over the past few years. While the use of ketamine decreased from 35.8% in 2015 to 13.9% in 2017, methamphetamine and cocaine have become the most commonly used psychotropic substances and account for more than 50% of drug abuses cases in 2017. Among all stimulants, methamphetamine is most commonly used because it releases three times more dopamine than cocaine and the effects can last from eight to twelve hours, compared to two hours for cocaine. On top of its extreme effects, methamphetamine is relatively inexpensive, making it even more accessible to the young population. Misuse of methamphetamine has long been associated with profound psychological and cognitive disturbance. In reviewing the cognitive data from reasonably well-matched groups of chronic methamphetamine users and healthy controls, the majority of studies have found that chronic methamphetamine users had lower scores on at least some cognitive tests, although some studies are exceptions with entirely nonsignificant differences. A meta-analysis of 17 cross-sectional studies found that chronic methamphetamine users demonstrated significantly lower cognitive scores than healthy controls. The effects were largest for measures of learning, executive functions, memory, and processing speed, although the majority of cognitive domains significantly differed between the groups. Concerns has been emerging regarding the methodology of the aforementioned results. In particular, the appropriateness of using healthy controls to examine the cognitive effects of stimulant use has been questioned. Much of the published research has fallen victim to using controls with significant baseline differences from the chronic stimulant users, such as years of education. In addition, none of the studies available provided scatter plots of their cognitive data to evaluate the overlap in performance between chronic stimulant users and healthy controls. In fact, many chronic stimulant users have normal cognitive function when compared with normative data. Therefore, the use of the term 'impairment' or 'deficit' in many studies is not fully justified. Another limitation is that it cannot differentiate cognitive weaknesses that may predate stimulant use from those that result from it. Notably, longitudinal studies have shown that childhood deficits in executive function can predict drug abuse in adolescence, suggesting that at least some of the cognitive weaknesses pre-exist in chronic stimulant user. These and other limitations provoked a conclusion that the evidence for cognitive deficits in chronic stimulant users is weak. In order to overcome the methodological issues observed in previous cross-sectional studies, we propose to conduct a prospective studies to determine the change in cognitive function among stimulant users over time.