164 Clinical Trials for Various Conditions
This research study is looking into the effects of clavulanic on smoking behavior in adult cigarette smokers. The primary study hypothesis is that, compared to placebo, clavulanic acid will reduce smoking over the course of the study.
The investigators' project has two overarching goals. 1) The investigators will use newly developed positron emission tomography (PET) technology to investigate the dopaminergic neurochemistry of drugs of abuse including marijuana, traditional cigarettes, and cocaine, and 2) The investigators will extend PET technology to an additional neurotransmitter system - namely, the opioid-ergic system, using the same drugs of abuse.
The purpose of this clinical trial is to evaluate the effectiveness and economic benefits of a Wage Supplement Model of arranging long-term exposure to employment-based abstinence reinforcement.
Background: - Researchers are interested in studying the roles that genes play in drug and alcohol addiction. Genes seem to account for about half of the differences between people who become addicted to drugs and people who do not. This study will collect blood and skin cell samples. These cells will be used to develop stem cells that are useful for studying how genes are related to drug use and dependence. Objectives: - To study genetic and cellular differences between people who are addicted to drugs and those who are not. Eligibility: * Individuals between 21 and 65 years of age who do not use drugs. * Individuals between 21 and 65 years of age who are in treatment with buprenorphine or methadone. Design: * Participants will be screened with a brief physical exam and medical history. * Participants will also answer questions about physical and mental health, quality of life, and history of drug and alcohol use. A urine sample and cheek swab sample will be collected. * Participants whose genetic samples match the study requirements will be asked to come back to provide a skin biopsy sample and a second urine sample.
This application is a competing continuation of a grant in which we developed and pilot tested a computerized Therapeutic Workplace designed to train and employ adults as data entry operators. A randomized trial is planned over 5 years to investigate the Therapeutic Workplace business as a maintenance intervention to sustain long-term abstinence and employment. Welfare recipients in methadone treatment, actively using cocaine, and at risk for contracting or spreading HIV infection will participate in an initial Therapeutic Workplace training phase. Participants who become abstinent and skilled will be randomly assigned to an Abstinence \& Employment, or an Employment Only group. Participants in the Abstinence \& Employment group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary. Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work. This study will provide a rigorous evaluation of the efficacy of the Therapeutic Workplace business as a long-term treatment of cocaine addiction and unemployment; determine the benefits of requiring daily evidence of abstinence to work; and provide information on the extent to which a Therapeutic Workplace business can become self-sustaining. This research could provide firm scientific foundation for the dissemination of Therapeutic Workplace businesses in the long-term treatment of cocaine addiction and unemployment. The main hypothesis being tested is that cocaine abstinence will be reliably maintained during the yearlong intervention evaluation period only in the group exposed to the explicit abstinence maintenance intervention. We expect that cocaine abstinence in the Abstinence and Employment group will be significantly greater than cocaine abstinence in the Employment Only group.
The purpose of this study is to determine whether long-term exposure to the Therapeutic Workplace intervention could sustain drug abstinence over an extended period of time in heroin- and cocaine-dependent, unemployed, treatment-resistant young mothers.
Poverty and opioid addiction are interrelated and chronic problems which have not been addressed adequately. The Therapeutic Workplace could treat the many adults with opioid use disorder who are unemployed and live in poverty. The Therapeutic Workplace pays participants to work. To promote drug abstinence, the Therapeutic Workplace arranges employment-based abstinence reinforcement in which participants are required to provide drug-free urine samples to maintain maximum wages. Many studies have shown that employment-based abstinence reinforcement in the Therapeutic Workplace can promote and maintain drug abstinence. Recently, the investigators showed that abstinence-contingent wage supplements in the Therapeutic Workplace could promote drug abstinence and employment and reduce poverty. However, the investigators have not demonstrated the real-world impacts of the Therapeutic Workplace. The Therapeutic Workplace requires two modifications to produce real world impacts. 1. The investigators must develop a real-world version of the Therapeutic Workplace that community treatment programs can implement. 2. The investigators must reduce the costs of maintaining employment-based abstinence reinforcement. This application seeks to develop and evaluate a low-cost Therapeutic Workplace that community treatment programs can implement and that addresses the persistent nature of opioid addiction and poverty. The investigators propose to conduct a Stage III study in which a community clinic (REACH Health Services) adapts and implements the Therapeutic Workplace intervention. To improve the feasibility of this intervention, the investigators will use low-cost abstinence-contingent wage supplements to maintain abstinence. The investigators propose to conduct a randomized controlled study to evaluate the effectiveness of the low-cost abstinence-contingent wage supplements in a community Therapeutic Workplace to maintain long-term drug abstinence and employment, and to reduce poverty in adults with opioid use disorder. All participants will be invited to attend a 4-week induction period and 48 weeks of support by an employment specialist. At the end of a 4-week induction period, REACH unemployed methadone or buprenorphine patients with opioid use disorder who meet the Induction Period inclusion criteria (N=225) will be randomly assigned to a "Usual Care Control," an "Initiation Only," or an "Initiation and Maintenance" group. All groups will be offered methadone or buprenorphine treatment and an employment specialist for 48 weeks. "Initiation Only" and "Initiation and Maintenance" participants will earn high magnitude abstinence-contingent wage supplements during a 24-week Initiation period (weeks 1-24). "Initiation and Maintenance" participants will also earn low-magnitude abstinence-contingent wage supplements during a 24-week Maintenance period (weeks 25-48). The investigators will base the primary outcome measures on assessments conducted every four weeks of the Maintenance period. If low-cost abstinence-contingent wage supplements in the community Therapeutic Workplace maintain drug abstinence and employment and decrease poverty, community drug abuse treatment clinics could apply this intervention widely as a long-term maintenance treatment for unemployed adults with opioid use disorder.
The purpose of this research is to examine the effect of cannabidiol (CBD), a cannabinoid compound found in marijuana, on responses to emotional stimuli. Both preclinical and clinical studies indicate that CBD may act to reduce anxiety without excessive sedative side-effects. Thus the investigators hypothesize that CBD may reduce responses specifically to negative emotional and social stimuli, including pictures and emotional faces, without altering responses to positive stimuli. To examine this, the investigators will administer placebo, 300mg, 600mg, and 900mg CBD to healthy normal adults in a double-blind within-subjects study. The investigators will measure subjective and subtle physical responses to positive and negative stimuli using measures that have been characterized with classic anxiety-reducing drugs and drugs of abuse. Further, the investigators will examine whether CBD-induced changes in these measures of emotional response relate to changes in actual behavior in a controlled social interaction. These results will allow the investigators to examine the potential usefulness of CBD as an anxiety-reducing drug, and suggest mechanisms by which CBD may reduce anxiety.
In Phase I of this R34, the team from the University of California Los Angeles, San Francisco, and Irvine researchers plan to utilize the successful community participatory approaches to refine a gender-sensitive criminogenic needs -focused intervention program, Female Ex-Offender Mentoring in Care (FEM-CARE), with the help of a community advisory board, composed of homeless female offenders (HFOs) and addiction staff; and finalize strategies which will be validated by focus group sessions with the HFOs. In Phase 2, the research team will randomize 130 HFOs participating in one of two residential drug treatment programs to assess the impact of the FEM-CARE or a Health Promotion control program on reduction of drug and alcohol use and recidivism. This study is based upon our team's history of promoting theoretically-based, culturally sensitive nurse-led interventions that are enriched with criminal justice theoretical perspectives, and have resulted in significant reductions in drug and alcohol use among homeless persons, many of whom have had a history of incarceration. Specifically, the study aims are: AIM 1) Guided by a Community Advisory Board (CAB) made up of HFOs and addiction staff, further conceptualize our community-based program, Female Ex-Offender Mentoring in Care (FEM-CARE), to address the needs and risks of HFOs enrolled in RDT programs, and then refine the program in focus group discussions with 12 HFOs. AIM 2) Conduct a pilot RCT to assess the impact of the FEM-CARE program for 65 HFOs at six-month follow-up compared with 65 HFOs receiving a control Health Promotion (HP) program, in terms of a) self-reported and/or objective measures of drug and alcohol use; and b) prevalence of recidivism and number of days to first reincarceration. Hypothesis 2a: HFOs in the FEM-CARE program will have less drug and alcohol use at six months than HFOs in the HP control program. Hypothesis 2b: FEM-CARE HFOs will have a lower prevalence of recidivism by six months and greater number of days to first reincarceration than HP control HFOs.
The main aim of the study is to investigate the effects of ±3,4-methylenedioxymethamphetamine (MDMA; ecstasy) on social and emotional processing in healthy humans. Ecstasy is a widely used recreational drug, with over 2 million Americans reporting use of the drug in 2006. With this number of users, and evidence that high doses of MDMA are neurotoxic in laboratory animals, the public health implications of ecstasy use may be substantial. Certain subjective effects of this drug distinguish it from other stimulants, and may contribute to its widespread use: That is, users report that ecstasy produces profound feelings of empathy and closeness to others. These so-called 'empathogenic' effects, which may reflect the distinctive neurochemical profile of action of the drug, have yet to be characterized in controlled laboratory studies. The investigators propose to characterize the effects of MDMA on measures of social and emotional processing that may contribute to this 'empathogenic' profile, including measures of emotion recognition, emotional responsiveness and sociability. The investigators will assess effects of MDMA (0, 0.75 and 1.5 mg/kg up to 125 mg) one active control drug (oxytocin: 20 IU) in 100 volunteers who report some prior ecstasy use. Oxytocin will be used because it appears to produce pro-social behavioral effects resembling those attributed to MDMA.
Classical conditioning is widely used to study motivational properties of addictive drugs in animals, but has rarely been used in humans. Here, we are establishing a procedure suitable for studying the neurobiology and individual determinants of classical conditioning in humans. Healthy volunteers are randomly assigned to four groups that received methamphetamine or placebo in the presence of distinctive environmental cues under paired or unpaired conditions. During each session, subjects perform tasks known to activate the ventral striatum in fMRI studies. The tasks are performed in the presence of a distinctive context, consisting of a screen background image of a beach or of mountains, accompanied by corresponding sounds. Separate groups of subjects carry out the tasks under high or low reward conditions. Within each of the two reward conditions, one group (paired), receives methamphetamine (20 mg, oral) or placebo consistently associated with one of the contexts, while the other (unpaired) receives drug or placebo unrelated to context. A fifth group (paired) perform the tasks with contextual cues but in the absence of monetary incentives. Before and after conditioning, participants carry out a series of forced choice tasks, and change of preference over time was analyzed.
The number of people seeking treatment for marijuana-related problems is on the rise, yet there is no currently accepted medication proven to help them quit. Frequent marijuana users have reported that they have trouble sleeping when they try to quit, and that the loss of sleep can lead to relapse. This research is designed to measure the severity of sleep problems in people as they are trying to quit heavy use of marijuana, and to investigate whether extended-release zolpidem (Ambien CR®) can improve quit rates among people trying to stop using marijuana.
Background: - The risk for becoming addicted to drugs varies among individual, even those using similar drugs in a similar way. It is not known why some people become addicted and others do not. Studies suggest that some genes may increase the risk of addiction. Negative life experiences may also affect the risk of addiction. Researchers want to test smokers and nonsmokers to study genetic and brain function traits that may lead to drug addiction. Objectives: - To understand brain function in people who may be at a higher risk of drug addiction. Eligibility: * Healthy volunteers between 18 and 55 years of age. * Smokers (10 to 30 cigarettes per day for more than 2 years) and nonsmokers will be eligible. Design: * Participants will be screened with a physical exam and medical history. They will be tested for drug and alcohol use. A blood sample will be collected. * The study will involve one visit. Participants will have a magnetic resonance imaging (MRI) scan. * At the visit, participants will answer questions about their health and drug use habits. They will then be trained on the tasks they will do during the MRI scan. After the training, they will have the scan and perform the tasks. The scan and tasks will look at brain function related to rewards and impulsiveness. * Other computer tests will be given after the scan. These tests will measure learning, memory, and impulsiveness.
Background: * Smoking is the leading cause of preventable death in the United States, and researchers are interested in gaining a better understanding of the perceived beneficial effects of nicotine to help improve treatment strategies for nicotine dependence. Understanding the conditions under which nicotine improves attention and cognitive processing may provide more useful information for this research. * The ability to pay attention and filter relevant from irrelevant stimuli is central to all aspects of information-processing. Top-down and bottom-up attentional processes illustrate how the brain combines stimuli and goal-directed behaviors. Bottom-up processing is an unconscious response to sensory input; for instance, when the eyes automatically focus on a prominent image in a picture. Top-down processing is a conscious response to drive attention toward specific stimuli; for instance, when a person is asked to focus on a less immediately noticeable image in a picture. Researchers are interested in determining whether nicotine improves cognitive performance by acting on top-down or bottom-up attentional mechanisms. Objectives: - To investigate the effect of nicotine on the top-down and bottom-up mechanisms of attention in cigarette smokers. Eligibility: - Current smokers (at least 10 cigarettes per day for at least 1 year) between 18 and 55 years of age. Design: * This study will involve one training session and four experimental sessions. * During the training session, participants will receive a sample dose of the nicotine nasal spray used in the study to determine if they can tolerate the effects. * For each experimental session, participants will receive one dose of nicotine nasal spray (1 mg, 2 mg, or 3 mg) or placebo spray, followed by blood pressure and heart rate monitoring, performance of an attentional test, and questionnaires to rate participants perception of nicotine effectiveness. Participants may receive different doses at different sessions, and will not be told which dose they will receive at any given point.
The purpose of this 2 year study is to conduct a fully powered effectiveness trial comparing recovery trajectories of 200 drug dependent adults (the subjects) who will be randomly assigned to Treatment as Usual (TAU) or TAU + Long-Term Recovery Management (LTRM).
This research compares the benefits of the original treatment, Community Reinforcement and Family Training (CRAFT), with the Treatment Entry Training (TEnT) component of CRAFT to determine if TEnt alone can produce the primary outcome of CRAFT -- treatment entry of the drug user. We also look at the impact on the well-being of the concerned significant other and the drug use of their loved one.
The overall objective of this research is to develop and refine empirically supported continuing care interventions that promote healthy behavior and sustained abstinence from illicit drug use.
For the past several years our research program has developed and tested an intensive outpatient intervention that is based in social learning theory and employs abstinence contingent access to recovery housing as a routine aspect of an intensive day treatment counseling program. The present project proposes to extend this treatment intervention to the special population of pregnant drug using women enrolled at the Center for Addiction and Pregnancy (CAP). We will compare an enhanced treatment that includes abstinence contingent recovery house living plus intensive individual therapy, to standard care at the CAP program. Specific aims of the project are derived from testing a two-group design are described below: 1. To determine whether financially supported abstinence-contingent recovery house placement plus individual counseling in pregnant drug-dependent women improves prenatal outpatient treatment retention. 2. To determine whether financially supported abstinence-contingent recovery house placement plus individual counseling in pregnant drug-dependent women reduces prenatal drug use. 3. To determine whether financially supported abstinence-contingent recovery house placement plus individual counseling results in better maternal and infant clinical birth outcomes (e.g., birth weight, estimated gestational age (EGA) at delivery, medical complications).
This is a two group randomized design that will compare a novel therapy package (i.e., Research supported treatment intervention, Contingency-based voucher incentives for the male partner's drug abstinence, Specialized MI couples counseling) to standard care for helping drug using partners of drug dependent pregnant women obtain and maintain drug abstinence. Participants will be followed for 22 weeks and have scheduled twice weekly urine sample collection and all participants will have follow-up interviews post-study entry.
Treatment studies have demonstrated that current smoking cessation techniques are less effective for women. The purpose of this study is to determine the role that gender plays in the effectiveness of nicotine replacement therapy. In addition, the purpose of this study is to determine whether men and women differ in their response to smoking-related stimuli (e.g., taste or smell of a lit cigarette). Conclusions drawn from this study may help to improve cessation interventions for all smokers, particularly women.
The primary objective of this study is to evaluate the ability of TOME to increase Medication for Opioid Use Disorder (MOUD) and opioid-overdose knowledge in pregnant and postpartum persons.
This study is evaluating the efficacy of Treatment A for short-term smoking cessation through a blinded randomized controlled trial (RCT) vs.Treatment B.
The primary objective of this study is to evaluate the impact of treating opioid use disorder (OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual buprenorphine (BUP-SL), on mother and infant outcomes. The primary hypothesis is that the BUP-XR group will not have greater illicit opioid use than the BUP-SL group during pregnancy (non-inferiority).
This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Caretakers of the infants delivered by MOMs participants will be offered the opportunity to enroll in this sub-study, which is designed to evaluate the impact of extended-release buprenorphine (BUP-XR), relative to sublingual buprenorphine (BUP-SL), on infant neurodevelopment. The additional data collected in this sub-study will be combined with data from the main MOMs trial.
This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which extended-release buprenorphine (BUP-XR), may improve mother-infant outcomes, compared to sublingual buprenorphine (BUP-SL). The additional data collected in this sub-study will be combined with data from the main MOMs trial. It is hypothesized that: (1) the buprenorphine blood levels will vary, depending on which formulation of buprenorphine was received, (2) the variation in buprenorphine blood levels will be associated with fetal behavior (including fetal heart rate variability) (3) the variation in buprenorphine blood levels will be associated with differences in mother outcomes (including medication adherence and illicit opioid use) (4) the variation in buprenorphine blood levels and in fetal behavior will be associated with infant outcomes (including neonatal opioid withdrawal syndrome and infant development).
Background: People with addictions often find it hard to choose the long-term benefits of abstinence over the short-term effects of using drugs. Researchers think this is partly due to parts of the brain involved in certain types of learning and decision-making. Researchers want to test these basic functions using a simple task with pictures and odors. Objective: To see if performance in a learning task differs between people who have opioid-use disorder and people who don t. Eligibility: Adults 21-60 years old who are willing to fast for at least 6 hours and smell food odors. Those with an opioid-use disorder must either not use for at least 3 weeks or be in treatment. Design: Participants will have 1 visit that will take up to 5 hours. Before the visit, participants will be asked to not eat or drink anything except water for at least 6 hours. At the visit, participants will be checked for signs of intoxication. Participants will give urine and breath samples. Participants will have tests of learning and behavior. They will look at shapes on a computer screen. The shapes will be paired with different food odors. The odors will come from a sterile tube placed under the nose. Participants will have their breathing monitored with a belt around the upper abdomen. About 30 days and 60 days later, participants will be called and asked about their drug use over the past 30 days. ...
This study is comparing the efficacy of two smoking cessation apps.
This project examines computer-delivered cognitive-behavioral intervention (CBT4CBT) as an adjunct to residential treatment for women with substance use disorders (SUD). The project will conduct a 2-arm randomized clinical trial (RCT) comparing post-discharge relapse rates for treatment as usual (TAU) with access to the CBT4CBT program vs. TAU in a residential sample of women with SUDs.
The purpose of this research study is to: 1. assess how well individuals entering medication assisted treatment like the RETAIN e-health application as measured by their feedback on the intervention. 2. test the impact of RETAIN on knowledge about medication-assisted treatment(MAT). 3. assess treatment retention rates in patients completing the RETAIN intervention. 4. test the impact of RETAIN on knowledge about HCV/HIV 5. test the impact of RETAIN on interest in being tested for HCV/HIV
The purpose of this research study is to: 1. assess how participants like the AWAITS e-health application as measured by their feedback on the intervention 2. test the impact of AWAITS on knowledge about opioid overdose and risk-reduction strategies. 3. assess the proportion of participants who accept a list of local treatment providers 4. test the impact of AWAITS on interest in being tested for HCV/HIV.