Active clinical trials for "Cocaine-Related Disorders"

The objective of this research is to identify the functional neural mechanisms (as assessed using fMRI) of short-term N-acetylcysteine (NAC) administration among methadone-maintained individuals with cocaine dependence.

Repeated drug consumption may progress to problematic use by triggering neuroplastic adaptations that attenuate sensitivity to natural rewards while increasing reactivity to craving and drug cues. Converging evidence suggests that glutamate modulation may work to correct these adaptations and rapidly restore motivation for delayed non-drug rewards relative to immediate drug use. Using an established laboratory model aimed at evaluating behavioral shifts in the salience of cocaine now vs. money later, the investigators will test the effect of CI-581a on cocaine self-administration as compared to the active control.

In this study, the investigators seek to evaluate the effects of cannabidiol (CBD) on cocaine craving and relapse. Cocaine addiction is characterized by compulsive substance use and repetitive urges to consume the drug even after a sustained period of abstinence. While substance use remains the most obvious direct outcome of addiction, there is a growing interest in other core symptoms of this disorder. Craving has become a subject of great interest as it is a reliable intermediate phenotype of cocaine relapse and a distressing symptom of addiction associated with suffering. Indeed, even after a period of abstinence, cocaine-dependent individuals remain vulnerable to stress and other craving-inducing stimuli, which, in turn, lead to intense physiological responses and various negative feelings such as anger and sadness. Real-time daily monitoring of craving and drug use has shown that craving predicts cocaine relapse among cocaine-dependent individuals. In sum, working toward improving the treatment of craving could not only help prevent relapse, but also reduce patient distress on emotional, cognitive, and physiological levels. In the past decades, significant scientific efforts have been deployed toward the development of innovative strategies to beat cocaine addiction, but with partial success thus far. Psychosocial approaches have been widely used to help cocaine-dependent patients achieve better outcomes after drug cessation, but literature indicates that these strategies alone are at times insufficient to induce significant behavioural changes or a reduction in rates of drug consumption. Unlike other types of addiction, such as opioid and alcohol, no pharmacological treatment has yet been found to be truly effective in relieving cocaine-cessation symptoms like craving and anxiety or to prevent relapse. CBD is a natural cannabinoid with a favourable tolerability profile and discrete neurobiological actions that are linked to neural circuits closely involved in addiction disorders. Addiction to cocaine is characterized by alternating phases of intoxication and short abstinence, followed by recurrent drug-craving episodes which result in distress and relapse. Our hypothesis is that CBD a cannabinoid known for its broad spectrum properties is an interesting pharmacological contender to decrease cocaine craving and treat cocaine addiction. Previous studies conducted in animals and humans confirm that CBD is a very safe and tolerable medication.

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.

The use of crack-cocaine is growing at alarming rate in our country and it is absolutely worrisome the fast establishment of addiction to it. Its immediate effects, that are intense and extremely fleeting, increase dramatically the probability of this drug to be consumed again, settling quickly down the loss of control and the compulsive use, turning the effects of this drug highly addictive. Parallel to this process, brain damages are quickly established, progressing to severe impairments of frontal functions, leading to the lack of cognitive control that feeds back and aggravates the dependence, and hampers any therapeutic approach. The existing treatments have not proved to be satisfactory yet. Thus, considering that a new modality of treatment, based on the neuromodulation induced by noninvasive brain stimulation, has been useful in treating various neuropsychiatric conditions, this study will examine the potential beneficial effects of repeated transcranial Direct Current Stimulation over the left dorsolateral prefrontal cortex in the treatment of crack-cocaine addiction.

The main purpose of this study is to determine the outcome of a drug combination treatment on detoxified and stabilized methamphetamine (METH) and/or cocaine (COC) dependent users. The combination regimen consists of oral administration of a generic immediate-release methylphenidate (MPh-IR) formulation (e.g., Ritalin®) and a novel delayed, pulsatile-release formulation of the antiemetic ondansetron (Ond-PR002). Various psychological assessment tools and functional magnetic resonance imaging (fMRI) will be used to assess the treatment outcome. In addition to the treatment outcome measures, we will determine whether the 14-day, once-a-day treatment leads to significant changes in the pharmacokinetic/pharmacodynamic (PK/PD), safety and tolerability parameters of MPh-IR and/or Ond-PR002 formulations and drug-drug interactions between the two drugs.

The objective of this study is to evaluate the safety and efficacy of Nepicastat in improving the number of subjects that achieve abstinence from cocaine and reducing cocaine use in subjects with cocaine dependence.

Cocaine dependence involves problematic neuroadaptations, such as heightened reactivity to cocaine cues, that may be responsive to pharmacological modulation of glutamatergic circuits. Despite promising preclinical findings with n-methyl-d-aspartate receptor (NMDAr) modulators, studies with human subjects have been unsuccessful to date. The purpose of this investigation is to examine the effects of the NMDAr antagonist ketamine, recently found to have potent therapeutic effects in humans, on cue-induced craving and impaired motivation for quitting cocaine in cocaine dependent participants, 24-hours post-infusion.

This study will test the efficacy of d-cycloserine in enhancing response to learning-based treatment for cocaine dependence, specifically contingency management.

More Americans are arrested for drug offenses than for any other crime. In 2009, over 294,000 arrests were made for possession of cocaine or heroin. Incarceration does not address the root problems and is frequently followed by relapse and re-arrest after release. In the case of opiate-dependent adults arrested for possession of heroin, one potentially effective alternative is to divert offenders to methadone maintenance treatment (MMT) as an alternative to adjudication of their case. MMT is an effective treatment for heroin dependence, and appears very effective for criminal offenders. However, cocaine use is common in MMT patients, including those with recent criminal justice involvement, and MMT alone is ineffective in addressing cocaine use. Continued cocaine use carries a substantial health burden and necessarily entails continued criminal activity. Thus, treatment for diverted opiate-dependent offenders should be designed to address cocaine use as well as opiate use. A Stage 1 Behavior Therapy Development project is planned over 2 years to adapt, manualize and pilot test the Therapeutic Workplace intervention for adults charged with heroin possession and offered diversion to methadone maintenance treatment as an alternative to adjudication of their case. The Therapeutic Workplace is a novel, employment-based contingency management intervention that has been very effective in promoting cocaine abstinence in adults who use cocaine persistently during methadone treatment. In the Therapeutic Workplace, participants are hired in a model workplace and required to provide drug-free urine samples to work and to earn maximum pay. Once we develop and manualize the adapted version of the Therapeutic Workplace for adults arrested for heroin possession, a pilot test will be conducted. Individuals identified by the State Attorney's office as candidates for diversion will be assessed for study eligibility. Given the high rates of injection drug use and injection-related transmission of HIV in Baltimore, this study will be restricted to injection drug users to evaluate the potential utility of this intervention in reducing HIV risk. Eligible individuals will be offered methadone maintenance in lieu of prosecution and will be required to remain in methadone treatment for 90 days. All participants will receive standard MMT, independent of whether they decide to participate in the pilot study. After beginning MMT, participants will be invited to enroll in the pilot study and randomly assigned to two study groups. Participants assigned to the Usual Care Diversion group will receive the standard MMT. Participants assigned to the Therapeutic Workplace Enhanced Diversion group will receive the standard MMT and the Therapeutic Workplace intervention. The data from this pilot study will serve as the foundation for a full-scaled randomized controlled trial. Overall, the Therapeutic Workplace could serve as a novel and ideal intervention for many heroin dependent adults involved in the criminal justice system. The use of MMT in lieu of adjudication in combination with the Therapeutic Workplace could increase drug abstinence and employment and decrease HIV risk and criminal activity in this refractory high-risk population.