A Randomized, Placebo and Active-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence
Probuphine (buprenorphine implant) is an implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This study will confirm the efficacy of Probuphine vs. placebo and compare Probuphine treatment verses treatment with sublingual buprenorphine in the treatment of patients with opioid dependence.
NCT01114308 — Opioid Dependency
Status: Completed
http://inclinicaltrials.com/opioid-dependency/NCT01114308/
The Clinical and Neural Response of Cocaine Addicts to Combination Treatment With a Cognitive Enhancer and Extinction-Based Psychotherapy
For this project, the investigators are interested in exploring a new way to extend and maintain drug abstinence in people who are addicted to crack cocaine. This study will combine a medication called D-Cycloserine (DCS) and weekly cognitive behavioral therapy (CBT) to assess whether the combination will enhance people's ability to stay clean (drug free) for longer periods of time. One of the greatest risks for drug relapse is drug craving. Oftentimes drug craving occurs when a person is confronted with stressors and reminders of past drug use behavior. DCS has been shown to enhance the learning of new information. By administering DCS prior to learning new techniques such as how to cope with drug craving and drug-use reminders, it is possible that patients can be more successful at living a drug free life for a longer period of time. In addition to exploring this model behaviorally, the investigators will explore changes that may occur in the brain before and after the therapy/medication intervention. A technique called MRI (Magnetic Resonance Imaging) will be used to identify areas of the brain that are being activated during an attention task. Areas of neural activation will be assessed at study entry, end of therapy (4-week endpoint) and one month following completion of the treatment program.
NCT01067846 — Cocaine Addiction
Status: Completed
http://inclinicaltrials.com/cocaine-addiction/NCT01067846/
Neurobiology of Nicotine and Non-nicotine Components of Tobacco Addiction
In the present study the investigators will measure the effects of nicotine and non-nicotine factors on brain function during cognitive processes that are differentially sensitive to these factors. One process—continuous working memory (CWM)—is implemented via a network of frontal and parietal brain regions and is highly dopamine dependent. Smoking cessation results in significant deficits in CWM which can persist for weeks and are reversed by resumption of nicotine administration in the form of smoking or nicotine replacement. Additionally, CWM deficits are observed during smoking of denic cigarettes. Brain function during CWM is modulated by smoking abstinence and subsequent nicotine administration and activity in the dlPFC is implicated in these effects. Collectively, these data suggest that CWM is highly sensitive to the nicotine, but not non-nicotine components of smoking. Brain function during CWM is altered by smoking abstinence and nicotine, but the effect of smoking, in the absence of nicotine, has not been evaluated. Another process—cue-reactivity (CR)—results from the repeated pairing of otherwise neutral stimuli with nicotine administration. Acute smoking cessation has not been shown to have strong effects on CR in the form of cue-provoked craving, nor has nicotine replacement been shown to have robust effects on CR. Likewise, the direct effects of smoking abstinence on brain CR have been small; though craving has been shown to modulate relations between abstinence and CR. Moreover, recent data from our lab suggest larger 'doses' of abstinence (~ 24 hrs) may amplify brain responses to cues. The effect of smoking in the absence of nicotine, on CR has not, to our knowledge, been evaluated. Collectively, these data suggest that CR in the form of cue-induced craving is not highly sensitive to the effects of short-term smoking abstinence or nicotine. Brain CR is modulated by abstinence-induced craving and longer-term abstinence, but it is unclear whether abstinence from nicotine or non-nicotine components is responsible for these effects. In the present study, we propose to evaluate the effects of non-nicotine and nicotine factors on CWM and CR using functional magnetic resonance imaging. This method allows for the non-invasive assessment of brain function. We will also examine the role of genes in moderating and mediating the effects of nicotine and non-nicotine factors on cognitive function
NCT01056926 — Smoking
Status: Completed
http://inclinicaltrials.com/smoking/NCT01056926/
Reward Processing in Cocaine Addiction
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.
NCT01036074 — Cocaine Dependence
Status: Completed
http://inclinicaltrials.com/cocaine-dependence/NCT01036074/
Pilot Study of Transcranial Magnetic Stimulation (TMS) in Nicotine Addiction
Background: - Treatment for nicotine addiction is characterized by high rates of relapse. New treatment therapies for nicotine addiction are exploring the use of brain scanning equipment to control and decrease nicotine and cigarette cravings. - Transcranial magnetic stimulation (TMS) uses magnetic pulses to stimulate the brain. These pulses can change activity in parts of the brain. Researchers are interested in determining whether TMS delivered in single pulses can decrease activity in the parts of the brain that respond to nicotine craving. Objectives: - To determine whether single pulse TMS can reduce cue-induced nicotine craving and use in cigarette smokers. Eligibility: - Individuals 18 years of age and older who are physically healthy and have smoked 10 or more cigarettes per day for at least 1 year. - A small group of healthy nonsmoking control subjects 18 years of age and older will also participate in the study. Design: - The study will involve seven study visits and two follow-up visits. The control participants will have only two visits: one with a magnetic resonance imaging (MRI) scan and one with TMS to evaluate brain function and response. - Participants will have an initial assessment about tobacco use habits and craving patterns, and will provide blood and urine samples before beginning the study. - Participants will have two initial MRI brain scans. The first scan will look at the structure of the brain at rest. During the other scan, participants will look at images related to and not related to cigarette smoking. - The single pulse TMS sessions (with either actual TMS or inactive [sham] TMS) will be held daily for 5 consecutive days. Magnetic pulses will be triggered by cigarette-related picture cues and delivered at varying intervals before the participant sees a cigarette-related picture. During these testing visits, researchers will ask questions related to tobacco use and craving, and collect urine and breath samples for further study. - Participants will have two follow-up visits, 1 week and 2 weeks after the TMS sessions, to evaluate memory and mood, and will have one final MRI brain scan at the end of the study.
NCT01031693 — Nicotine Dependence
Status: Completed
http://inclinicaltrials.com/nicotine-dependence/NCT01031693/
A Double-Blind Placebo Control Study on the Use of Nabilone for Outpatient Management of Acute Marijuana Withdrawal
Safety of Nabilone in reducing marijuana craving
NCT01025700 — Marijuana Smoking
Status: Completed
http://inclinicaltrials.com/marijuana-smoking/NCT01025700/
A Pilot Trial of Naltrexone for Methamphetamine Addiction - Role of the A118G SNP
The purpose of this study is to determine whether methamphetamine-dependent individuals will use less methamphetamine when treated with naltrexone. The study will also investigate whether individuals with the mu opioid receptor gene variant A118G will use less methamphetamine than individuals without A118G.
NCT00984360 — Methamphetamine Dependence
Status: Completed
http://inclinicaltrials.com/methamphetamine-dependence/NCT00984360/
Randomized Control Trial (RCT) Evaluating Improvement Strategies in Addiction Treatment
Addiction treatment is often characterized by long delays between first contact and treatment as well as high no-show and drop out rates leading to unused capacity in apparently full agencies. Patients do not get needed care and agency financial stability is threatened. The Network for Improvement of Addiction Treatment (NIATx) began as a high-intensity improvement collaborative of 39 addiction treatment agencies distributed across 25 states. NIATx substantially improved time to treatment and continuation in treatment by making improvements to organizational processes (such as first contact, intake and assessment, engagement, level of care transitions, paperwork, social support, outreach, and scheduling) in preliminary studies. While the results are very encouraging, they have, by intent, been obtained from a select group of agencies using a high-cost combination of services. A more practical diffusion model is needed to spread process improvements across the spectrum of treatment agencies. This study is a cluster-randomized trial to test the effectiveness and cost of less expensive combinations of the services that make up the NIATx collaborative (interest circles, coach calls, coach visits and learning sessions).
NCT00934141 — Addiction
Status: Completed
http://inclinicaltrials.com/addiction/NCT00934141/
Pharmacogenomics and Medication Development for Methamphetamine Dependence
Currently there are no medications approved for the treatment of methamphetamine addiction. Bupropion is an antidepressant that is approved by the Food and Drug Administration (FDA) for the treatment of depression and for cigarette smoking cessation but is not approved by the FDA for the treatment of methamphetamine addiction. Preliminary research studies suggest that bupropion may help people receiving treatment for methamphetamine addiction to reduce or to stop their methamphetamine use. But results of these studies also suggest that bupropion may help certain groups of patients more than others, such as men versus women and light versus heavy methamphetamine users, although the reasons for this difference are not known. One possibility is that a person's genetic make up may influence whether or not they respond to treatment with bupropion for methamphetamine addiction. The purpose of the study is to determine if bupropion is can help people reduce or stop their methamphetamine use and to investigate whether genetic variations influence whether people respond to treatment with bupropion for methamphetamine addiction, which may help doctors and patients better decide if treatment with bupropion will be beneficial or not. To identify possible genetic variations that influence response to bupropion, we will perform genetic tests on blood or saliva specimens from participants receiving treatment with either bupropion or placebo (which is a pill that contains no medication) in conjunction with standard cognitive behavioral therapy drug counseling. We will compare methamphetamine use, as assessed with urine drug screens, among participants receiving bupropion versus those receiving placebo to determine if bupropion helps people to reduce or stop their methamphetamine use. We will then compare the results of the genetic tests among participants who respond and who do not respond to bupropion. In addition, since the amount of methamphetamine a person uses was associated with response to bupropion in preliminary studies, we will also compare the results of genetic testing among persons with heavy versus light methamphetamine use before entering treatment. Results of this study have the potential to provide insights into the biology of methamphetamine addiction and help increase the understanding of how bupropion works. This information could be useful to develop effective medications for methamphetamine addiction and to improve the ability of clinicians to provide treatment to patients with methamphetamine addiction.
NCT00833443 — Substance Abuse
Status: Completed
http://inclinicaltrials.com/substance-abuse/NCT00833443/
Impact for Care for Patients With Alcohol Addiction and Treated for ORL Cancer
The aim of the study is to compare the hospitalisation period in ORL surgery for two groups of patients. One of them will be treated for alcohol addiction to weaning them before the surgery ORL. The other group will be treated with usual methods.
NCT00825448 — Alcoholism
Status: Recruiting
http://inclinicaltrials.com/alcoholism/NCT00825448/