Loading clinical trials...
Loading clinical trials...
Showing 1-20 of 35 trials
NCT02455479
The purpose of this study is to assess the safety and preliminary efficacy of an anti-cocaine vaccine called dAd5GNE in cocaine-dependent individuals. It uses the concept of a vaccine to treat the neurological effects of cocaine by evoking "immunity" to prevent the effects of cocaine on the brain.
NCT05974202
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. The former principle investigator, Dr. Derek Blevins, has vacated his position (February 2025), and has transferred the principle investigator role to Dr. John Mariani, the STARS Clinic Director.
NCT04907357
The purpose of the study is to determine feasibility of repetitive transcranial magnetic stimulation (rTMS) for individuals with moderate to severe cocaine or methamphetamine use disorder (CUD/MUD). Potential participants will be age 18-65, and interested in cutting down or stopping use. Participants will be randomized to one of two groups; groups will receive rTMS or sham rTMS (placebo) over the course of an 8-week treatment period, and complete follow-up assessments at the end of treatment, 12, and 16 weeks post-randomization.
NCT02111798
This project will examine effects of bupropion extended release (XL) at a dose of 300mg/day for cocaine abstinence among persons receiving methadone for the treatment of opioid use disorder. Participants also earned financial incentives for providing urine samples that tested negative for cocaine. Bupropion was examined for this purpose because of its previously demonstrated efficacy and safety as well as its pharmacological actions at dopamine systems. Participants were randomly assigned to bupropion XL vs. placebo and received different incentive schedules depending on whether they demonstrated abstinence from cocaine early in the study. Outcomes were tracked over a 6-month time frame and the overarching hypothesis was that bupropion (as compared to placebo) would increase the number of urine samples testing negative for cocaine, independent of whether participants demonstrated abstinence from cocaine early in the study.
NCT02927236
Objective: The goal of this clinical trial is to assess the tolerability of an accelerated intermittent theta burst stimulation (iTBS), a form of transcranial magnetic stimulation, intervention in participants with cocaine use disorder and then to determine if the intervention changes brain circuits related to cocaine use disorder and whether these changes relate to clinical outcomes. The main questions it aims to answer are: * Can individuals with cocaine use disorder tolerate accelerated iTBS (3 treatments per day for 10 days) (Pilot study)? * Does iTBS (compared to sham iTBS) alter brain circuits related to cocaine use disorder (Expanded feasibility study)? Researchers will compare individuals with cocaine use disorder to those without cocaine use disorder to identify differences at baseline, compare effects of the first day of iTBS treatment, and see if changes after treatment align brain circuits in those with cocaine use disorder more closely to patterns seen in those without cocaine use disorder. Participants will: * Undergo 10 days of iTBS treatment and two follow-up visits (1 week and 4 weeks after treatment) and complete questionnaires throughout to assess tolerability and drug use (Pilot study). * Participants with cocaine use disorder will complete a characterization phase with questionnaires, two fMRI scans and a trial session of iTBS (sham or active) before the treatment phase (Expanded feasibility study).
NCT06125054
The goal of this clinical trial is to learn about the effects of the combination of ketamine and realtime functional magnetic resonance imaging (fMRI) neurofeedback training in individuals with cocaine use disorder. The main questions the investigators aim to answer are: * Can the investigators observe a positive, significant effect on percentage of cocaine use days of both interventions combined as well as stand alone interventions? * Is there a significant transfer effect of the neurofeedback training? * Is there a significant, ketamine-dependent change in glutamate levels in the nucleus accumbens? Participants will be given ketamine and a realtime fMRI neurofeedback training. Both interventions are placebo-controlled. The investigators will compare the four intervention groups to investigate the effects of the stand-alone effects of the intervention and the combination of it.
NCT03471182
The proposed research program will investigate the changes in brain chemistry and circuitry that 're-wire' the brain during chronic cocaine use, promote relapse, and complicate treatment efforts. Currently-using and non-treatment-seeking individuals with a cocaine use disorder will undergo a cocaine self-administration paradigm 2-5 days prior to completing positron emission tomography (PET) and functional magnetic resonance imaging (fMRI).
NCT06189690
This study aims to explore the effect of 5-Hz rTMS over the left dorsolateral prefrontal cortex on the BDNF, craving and cognitive function. This study will be longitudinal, with a short-term double-blind placebo-controlled phase consisting of 20 rTMS sessions and a long-term phase, consisting of 2 weekly sessions for 12 weeks. Participants will be clinically assessed pre-treatment (T0), after 20-sessions phase (T1) and after 12-weeks phase (T2) by an interview about psychiatric symptoms. Also, blood will be obtained in the same T0, T1 and T2 to peripheral levels of BDNF determination. Cognitive state will be measured at the same time-points (T0, T1, T2) by paper-pencil and computerized neuropsychological assessment. Researchers will compare active rTMS versus placebo 5 Hz-rTMS on described variables. Additionally, a comparative group (without rTMS intervention) will be included to equivalently measure described variables during periods without cocaine consumption.
NCT02124941
This study is designed to look at the relationship between brain glucose utilization, neurotransmission (e.g., glutamate, also known as the main excitatory amino-acid neurotransmitter in the brain), and synaptic density. This relationship will be explored in the brain's prefrontal cortex, an area important in decision-making and impulsivity.
NCT02538744
The investigators will assess the impact of treatment with doxazosin and modafinil, alone and in combination, on the subjective and reinforcing effects of cocaine in non-treatment-seeking, cocaine-dependent volunteers. The investigators will use a hybrid design in which participants will be randomized into two groups: placebo and doxazosin 8 mg/d. They will remain in their assigned group for the duration of the study. After titrating doxazosin to the target dose, study procedures will be completed three times, once during treatment with each dose of modafinil (0, 200, and 300 mg/d), in pseudo-random order such that 200 mg precedes 300 mg).
NCT00838981
The purpose of this study is to compare the efficacy of the combined treatment modafinil + Contingency Management (CM) to either treatment condition alone or to yoked-controls on cocaine abstinence. To investigate the role of modafinil-related improvements in memory, impulse control, and attention in mediating cocaine abstinence.
NCT03921151
This project will evaluate the role of the 5-HT2CR:5-HT2AR balance in impulsive action and cue reactivity in cocaine-dependent subjects as compared to non-drug using controls.
NCT00780702
Background: * The effectiveness of methadone maintenance for treatment of heroin addiction has been well established. However, patients maintained on methadone may relapse to cocaine use, even when they are enrolled in a comprehensive treatment program. Relapse has been attributed to several factors, including drug-associated environmental stimuli. * Aripiprazole is a drug used to treat schizophrenia and bipolar disorder, but it may have other uses. Research has shown that aripiprazole can reduce cocaine-seeking behavior in rats, and it has been investigated for use in treating amphetamine dependence. More research is needed to determine whether aripiprazole can prevent relapse to cocaine use in patients being treated with methadone. Objectives: \- To determine whether aripiprazole prevents relapse to cocaine use more effectively than placebo in cocaine-abstinent patients maintained on methadone. Eligibility: \- Individuals between 18 and 60 years of age who are current cocaine users seeking methadone treatment. Design: * The study will last up to 41 weeks, with four phases of treatment and a follow-up evaluation. Three times a week, participants will be asked to report illicit drug use and provide urine and breath samples. Throughout the study, participants will receive individual counseling in weekly 40 60 minute sessions. Other samples and tests will be scheduled as required by the study researchers. * Patients will be stabilized on daily methadone over the first 14 days of the study. * Weeks 1 14: Participants will receive vouchers for regular cocaine-free urine samples. Those who successfully complete this phase will continue to the next part of the study. * Weeks 13 27: Participants will receive either aripiprazole or placebo along with their methadone. During this part of the study, participants will keep electronic diaries to record cocaine use or craving and to record data on mood and activity. * Weeks 28 33: Participants will stop taking the aripiprazole or placebo, but will continue the methadone treatment. Participants will continue to use the electronic diaries. * Weeks 34 41: Participants will have the choice of transferring to a community clinic or gradually reducing doses of methadone to end the study. * Participants will return for a follow-up visit and urine sample 6 months after the end of the study.
NCT01038232
Background: \- People who are in treatment for substance abuse often feel distress during the withdrawal period and afterward. Some individuals feel distress more acutely than others, and this distress has been linked to poor treatment outcomes and increased risk of relapse in smokers, alcoholics, and cocaine- and heroin-dependent individuals. More research is needed on the effects of distress on the brain, particularly in individuals who are seeking treatment for substance abuse. Researchers are interested in using functional magnetic resonance imaging (fMRI) scanning to study distress tolerance in both substance users seeking treatment and healthy non-drug-using volunteers. Objectives: \- To use functional magnetic resonance imaging to study the effectiveness of a distress tolerance assessment. Eligibility: \- Individuals between 18 and 50 years of age who are either cocaine dependent or healthy non-drug-using volunteers. Design: * This study involves an initial screening visit and a scanning visit, with four followup visits. * Participants will be screened with a medical history and physical examination, as well as blood samples and questionnaires about mood and past and current drug use. * Participants will have a structural MRI scan of the brain to provide a baseline reading for comparison. Participants will then have an fMRI scanning session, which will include both the distress tolerance assessment and relevant control tasks. Heart rate, blood pressure, and other physical reactions will be monitored throughout the scan. Participants will also provide blood and saliva samples to measure stress hormone levels. * Participants will be eligible to have followup assessments with fMRI scanning 1, 3, 6, and 12 months after the scanning visit.
NCT00783276
The dopamine system is critical in modulation of reward and has been implicated in the initiation and maintenance of addiction (Volkow et al 2004). Medications that increase dopamine either directly or indirectly have been shown to have preliminary efficacy at reducing cocaine use in cocaine dependent subjects (Grabowski et al 2004a; Schmitz et al 2008). A novel class of medications that has recently been shown to indirectly modulate dopamine function is adenosine A2A receptor antagonists (Fuxe et al 2007). Based on their effect on dopamine function it has been suggested that these compounds may be efficacious in the treatment of drug addiction (Ferre et al 2007c). Before clinical efficacy studies are undertaken, more basic research on the effects of adenosine A2A antagonists on brain function and behavior are warranted. The aim of this study is to examine the acute effects of a single dose of the selective adenosine A2A antagonist (SYN115, Synosia Therapeutics, Chemical name: 4-Hydroxy-4-methyl-piperidine-1-carboxylic acid-(4-methoxy-7-morpholin-4-yl-benzothiazol-2-yl)-amide) on brain function and behavior in cocaine dependent individuals using functional magnetic resonance imaging (fMRI). To examine the effect of a single dose of SYN115 on brain function and behavior in cocaine dependent subjects. Hypotheses: 1. SYN115 100 mg will increase brain activation in the dorsolateral prefrontal cortex compared to placebo in cocaine dependent subjects performing a working memory task. 2. SYN115 100 mg will increase brain activation in the ventral striatum compared to placebo in cocaine dependent subjects performing a reversal learning task. 3. SYN115 100 mg will reduce brain activation in the anterior cingulate gyrus and amygdala compared to placebo in cocaine dependent subjects performing a cocaine-word Stroop task.
NCT02935101
The purpose of this study is to evaluate whether prednisolone lowers intensity and frequency of craving in heroin-addicted subjects undertaking a detoxification of cocaine and/or heroin.
NCT01906346
Cocaine-use disorders continue to be a significant public health concern, yet no effective medications have been identified. The goal of this study is to establish a research platform for the development of medications for treatment of cocaine abuse and dependence. This study will incorporate self-administration procedures and a non-drug alternative reinforcer, which is hypothesized to reduce the reinforcing effects of cocaine.
NCT00732901
The purpose of this study is to examine the relationship between 5-HT2R function, impulsivity and cue reactivity in cocaine dependent subjects and healthy controls and examine specific effects of escitalopram and mirtazapine on impulsivity and cue reactivity in human cocaine users.
NCT00240227
This double-blind placebo controlled crossover pilot trial will test the hypothesis that prazosin, an alpha-1 adrenergic receptor antagonist, reduces craving for their drug of choice in cocaine-dependent and alcohol-dependent veterans. Both the study medication period and the placebo period are each 4 weeks in duration.
NCT01963091
Stress is associated with drug craving and relapse in substance-dependent individuals. Hormones released from the brain may mediate the behavioral response to stress. For example, several studies have indicated that oxytocin reduces stress in laboratory stress paradigms. Specifically, it appears that oxytocin promotes trust, social interaction, and calmness; yet, little is known about the potential affects of oxytocin in cocaine-dependent individuals. Given these properties of oxytocin, it may have a therapeutic role in ameliorating the negative affect commonly observed prior to relapse in cocaine-dependent individuals, as well as the anxiety associated with withdrawal. This pilot protocol will provide important preliminary data on the effect of oxytocin on stress in cocaine-dependent individuals.