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Cocaine Dependence clinical trials

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NCT ID: NCT01038232 Completed - Cocaine Dependence Clinical Trials

Measuring Distress Tolerance With Functional MRI

Start date: December 4, 2009
Phase:
Study type: Observational

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.

NCT ID: NCT01036516 Completed - Cocaine Dependence Clinical Trials

PET Assays of Striatal Dopamine Marker in Cocaine Craving

Start date: June 23, 1998
Phase: N/A
Study type: Observational

Background: - Cues related to past drug use induce a particular pattern of brain activation, which has been correlated with craving for cocaine in active cocaine abusers. Researchers are interested in determining the role of the brain chemical dopamine in cue-elicited as well as spontaneous craving for cocaine. - To study the role of dopamine in cocaine craving, researchers will use positron emission tomography (PET) to compare the neural reactions of cocaine users with those of non-substance-abusing healthy volunteers. Researchers hope that the data gathered from this study will lead to the development of more effective anti-craving medications. Objectives: - To clarify the role of dopamine in cue-elicited responses that contribute to cocaine abuse. - To determine if PET results of this study differ with various means of administering PET chemicals. Eligibility: - Individuals 21 to 44 years of age who are either current cocaine users (at least twice per week) or healthy volunteers without a history of drug abuse. Design: - Cocaine-using participants will enter the inpatient clinical research ward at the National Institute on Drug Abuse (NIDA) Addiction Research Center for 2 nights before the day of the study. In addition, these participants will stay overnight at NIDA the evening after each PET session and will be discharged the following day. Cocaine-using participants will be required to perform a balance test before the study to provide a baseline response in case they require anti-anxiety medications to cope with the effects of the study. - Control subjects will not be required to stay overnight and will arrive as outpatients for the PET session. All participants will be required to abstain from alcohol and caffeine consumption from midnight before each study session, and will not be permitted to smoke on the day of testing. - - On the day of the study, participants will undergo a practice session to set up the PET scanning equipment. Following the practice session, participants will be shown video recordings of images that are related to nature (e.g., seashells) or to drug abuse (e.g., drug paraphernalia). Participant reactions will be studied through the PET monitoring, and the study will be conducted in two separate PET sessions with a break in between. Individuals in the cocaine-using group may receive anti-anxiety medication if the stimulus cues increase anxiety related to cocaine craving. - Different groups of participants will receive different methods of PET chemical administration, and researchers will compare these methods.

NCT ID: NCT01036074 Completed - Cocaine Dependence Clinical Trials

Reward Processing in Cocaine Addiction

Start date: March 17, 2005
Phase:
Study type: Observational

Background: - Cocaine affects the brain's ability to process information. However, different people respond to cocaine in different ways, and differences in brain structure and function may affect how cocaine alters brain activity. By using functional magnetic resonance imaging (fMRI) to monitor brain activity during tasks that provide simple rewards, researchers hope to better understand how the brain responds to rewards and how this response is affected by drugs like cocaine. Objectives: - To determine the effect of cocaine administration on the reward experience in cocaine-dependent individuals. - To study genetic and personality factors that may contribute to cocaine dependence. Eligibility: - Individuals between 18 and 45 years of age who either are cocaine-dependent and not seeking treatment or are healthy volunteers. Design: - Participants will be asked to avoid consuming alcohol and restrict consumption of caffeine prior to the study. Participants provide urine and breath samples to be tested for chemicals that may interfere with the study. - All participants will complete a training session and at least one fMRI scanning session. During the training session, participants will be introduced to the reward tasks and MRI equipment. - Healthy volunteers will have a single fMRI session that will involve reward tasks to be completed during the scanning. Rewards will include small amounts of fruit juice and the opportunity to win money. - Cocaine-dependent participants will have a training session and three experimental sessions including 1) a mock MRI scan to test cocaine tolerance, 2) one fMRI scan with reward tasks after administration of IV cocaine, and 3) one fMRI scan with reward tasks after administration of IV placebo (saline solution). Rewards will include small amounts of fruit juice and the opportunity to win money. - In addition to the scans, participants will provide a blood sample for further study and will answer questionnaires provided by the researchers.

NCT ID: NCT01032135 Completed - Cocaine Dependence Clinical Trials

Adaptive Treatment for Cocaine Dependence

Start date: October 2008
Phase: Phase 2/Phase 3
Study type: Interventional

1. Primary objective #1: Determine the relative effectiveness of MI-IOP and MI-PC in the full study sample with regard to treatment engagement over weeks 1-12 and cocaine use over weeks 1-24. - Hypothesis 1: An intervention that explores several possible treatment options with the patient and provides the chosen option (e.g., MI-PC) will produce higher rates of treatment engagement than an intervention focused on engagement in IOP only (e.g., MI-IOP). - Hypothesis 2: An intervention that explores several possible treatment options with the patient and provides the chosen option (e.g., MI-PC) will produce better cocaine use outcomes than an intervention focused on engagement in IOP only (MI-IOP). - Secondary analysis 1: Among the Non-engaged patients, determine rates of selection of each of the three options in MI-PC, retention rates within each option, and cocaine use outcomes in each option. - Secondary analysis 2: Among the Engaged patients, determine rates of selection of each of the three options in MI-PC, retention rates within each option, and cocaine use outcomes in each option. 2. Primary objective #2: Determine whether the relative effectiveness of MI-IOP and MI-PC varies as a function of engagement group, with regard to treatment engagement over weeks 1-12 and cocaine use outcomes over weeks 1-24. - Hypothesis 1: The predicted main effect on retention favoring MI-PC over MI-IOP will be significantly larger among patients in the Non-engaged group than among those in the Engaged group. - Hypothesis 2: The predicted main effect on cocaine use outcomes favoring MI-PC over MI-IOP will be significantly larger among patients in the Non-engaged group than among those in the Engaged group.

NCT ID: NCT01031563 Completed - Schizophrenia Clinical Trials

Risk Perception in Drug-Dependent Adults With and Without Schizophrenia

Start date: August 18, 2009
Phase: N/A
Study type: Observational

Background: - Several studies of risk perception have demonstrated a common bias known as unrealistic optimism, in which individuals feel they are less likely than other people to experience unpleasant or harmful events in their lives, but more likely to experience pleasant or beneficial events. - Previous research has indicated that individuals with schizophrenia have less of a sense of unrealistic optimism about adverse events than individuals without schizophrenia. However, research on risk perception in schizophrenia is sparse, primarily reporting on behaviors and decisions in the laboratory that likely are influenced by risk perception. - Risk perception among substance users may be viewed in two separate categories: perception of vulnerability to adverse events and perception of vulnerability to negative outcomes associated with substance use. Research in both areas has yielded mixed results. Researchers are interested in studying the connections among schizophrenia, addiction, and risk perception in order to develop better drug use prevention and treatment programs for people with and without schizophrenia. Objectives: - To compare unrealistic optimism bias in people with and without schizophrenia and/or drug dependence, and its association with actual risky behavior. Eligibility: - Individuals between 18 and 64 years of age who fall into one of the following study categories: - diagnoses of both drug dependence (marijuana or cocaine) and schizophrenia/schizoaffective disorder - diagnosis of drug dependence only (marijuana or cocaine) - diagnosis of schizophrenia/schizoaffective disorder only - healthy volunteers with no history of drug use or serious mental disorder Design: - The study will require a single visit to the research center for a 5- to 6-hour session. - Participants will complete questionnaires on medical and behavioral history, complete tests of thinking skills like memory and attention, complete a brief computerized decision-making task, and answer questions about risk perception. - Participants will also provide urine samples and breath carbon monoxide measurements to test for recent use of tobacco and other substances.

NCT ID: NCT01030692 Completed - Substance Abuse Clinical Trials

Rivastigmine and Huperzine A as Treatments for Cocaine Dependence

Start date: January 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and effects of rivastigmine and huperzine A (HupA), potential treatments for cocaine abuse, when used before experimental administration of cocaine, on a number of physical and psychological measures.

NCT ID: NCT00969943 Completed - Cocaine Dependence Clinical Trials

Gender Differences in Response to Cues in Cocaine Dependence

Start date: March 2003
Phase:
Study type: Observational

The purpose of this study is to evaluate whether men and women respond differently to seeing items related to cocaine use or to remembering stressful events. Four groups of individuals will be recruited to participate in this study: men with cocaine dependence, women with cocaine dependence, men without cocaine dependence, and women without cocaine dependence. Hypothesis #1: Cocaine-dependent women will demonstrate smaller increases in neuroendocrine, but greater increases in heart rate and more cocaine craving and subjective distress when exposed to stress as compared to cocaine-dependent men and non cocaine-dependent men and women. Hypothesis #2: Cocaine-dependent men will demonstrate greater increases in neuroendocrine, but greater increases in heart rate and more cocaine craving and subjective distress when exposed to cocaine-related cues as compared to cocaine-dependent women and non cocaine-dependent men and women. Hypothesis #3: Cocaine-dependent women will demonstrate greater increases in heart rate and more cocaine craving and subjective distress when exposed to stress inducing stimuli as compared to their own responses to a cocaine-related cue. Hypothesis #4: The neuroendocrine response to a stress hormone (corticotropin releasing hormone; CRH) will be greater in cocaine-dependent women as compared to cocaine-dependent men.

NCT ID: NCT00969878 Completed - Cocaine Dependence Clinical Trials

Multisite Controlled Trial of Cocaine Vaccine

TA-CD
Start date: August 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test the efficacy of a newly developed active vaccine against cocaine (TA-CD).

NCT ID: NCT00965263 Completed - Cocaine Dependence Clinical Trials

Therapeutic Cocaine Vaccine: Human Laboratory Study

Start date: March 2003
Phase: Phase 2
Study type: Interventional

Clinical data demonstrate that a cocaine vaccine (TA-CD: Celtic Pharmaceutical) produces selective anti-cocaine antibodies, yet the impact of these antibodies on cocaine's direct effects is unknown. The objective of this human laboratory study was to measure the relationship between antibody titers and the effects of smoked cocaine on ratings of intoxication, craving and cardiovascular effects. Cocaine-dependent volunteers not seeking drug treatment spend 2 nights per week for 13 weeks inpatient where the effects of cocaine (0, 25, 50 mg) are determined prior to vaccination and at weekly intervals thereafter. Vaccinations occur at weeks 1, 3, 5 and 9.

NCT ID: NCT00958282 Completed - Cocaine Dependence Clinical Trials

Treatment of Cocaine Dependence With Lisdexamfetamine

Start date: July 2009
Phase: Phase 2
Study type: Interventional

This protocol is a 2-group double-blind placebo-controlled outpatient study investigating lisdexamfetamine for treatment of cocaine dependence. The investigators plan to enroll 100 subjects in a 14-week trial. The primary objectives will determine changes in cocaine use and secondary objectives will be cocaine craving and impulsivity.