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Substance-Related Disorders clinical trials

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NCT ID: NCT00951314 Terminated - Cocaine Dependence Clinical Trials

Brain Glutamate Receptors and Cocaine Dependence

Start date: July 14, 2009
Phase:
Study type: Observational

Objective: Cocaine addiction continues to be an important public health problem with over 1.7 million users in the US alone. Cocaine addiction is characterized by compulsive drug use despite adverse consequences and high rates of relapse during periods of abstinence. Cocaine addiction may be mediated by neuroadaptations in reward-related learning and memory processes in the mesocorticolimbic dopamine system and glutamatergic corticolimbic circuitry. Metabotropic glutamate subtype 5 receptors (mGluR5) likely play essential roles in mediating some of the actions of drugs of abuse. Animal studies have shown that mGluR5 knock-out or blockade reduces self-administration of cocaine and cocaine-induced hyper-locomotion. However, to what extent mGluR5 are involved in the pathophysiology of cocaine addiction in humans is currently unknown, partly due to the lack of suitable methods to reliably quantify mGluR5 in the living human brain. This protocol aims to determine whether the density of mGluR5 in brain is altered in participants with cocaine addiction compared to healthy controls using positron emission tomography (PET) and the recently developed radiotracer for mGluR5, [18F]SP203. We also aim to determine whether this density is related to genotype, history of cocaine use, and/or craving for cocaine. Study Population: The study populations will consist of healthy adults with no history of substance abuse and a matched group of healthy current primary cocaine dependent male and female participants (20-50 years old.; N=40/group). Design: Density of mGluR5 will be measured in cocaine dependent participants and healthy adults volunteers with PET and (18F)SP203, a radioligand with specificity for mGluR5. All participants will undergo genotyping to identify normal or variant mGluR5 gene associated with drug abuse. The intensity of craving for cocaine will be assessed while watching a video about cocaine use. Outcome measures: Density of mGluR5 will be compared between cocaine dependent participants and healthy controls. In addition, correlation among the genetic polymorphism, the craving response, and the density of mGluR5 will be determined.

NCT ID: NCT00944554 Completed - Smoking Cessation Clinical Trials

Relapse Prevention With Varenicline

0815
Start date: October 2008
Phase: Phase 4
Study type: Interventional

This study aims to determine if varenicline (Chantix®), currently used as a smoking cessation aid, will decrease the likelihood of relapse to smoking following a programmed lapse in the laboratory. The hypothesis is that varenicline will reduce the reinforcing effects of smoking and will delay or prevent relapse compared to placebo.

NCT ID: NCT00936299 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Bupropion for ADHD in Adolescents With Substance Use Disorder

Start date: January 2009
Phase: Phase 4
Study type: Interventional

Attention deficit hyperactivity disorder (ADHD) is one of the most common co-occurring psychiatric disorders (30-50%) in adolescents with substance use disorders (SUD). Yet, little is known about the safety and efficacy of medications for ADHD in adolescents with SUD, since such youths have been excluded from most medication trials. Clinicians are therefore understandably reluctant to treat ADHD in substance abusing adolescents, often first referring such youths to substance treatment. Untreated ADHD is associated with poorer substance treatment outcomes. We address this research gap by proposing a randomized controlled trial of bupropion vs placebo in 130 adolescents (13-19 years) with Diagnostic and Statistical Manual (DSM IV) ADHD, nicotine dependence and cannabis use disorder (not excluding other SUD). Participants in both bupropion and placebo treatment groups will receive weekly individual manualized-standardized cognitive behavioral therapy (CBT) targeting SUD (at no cost to them) throughout the 16 weeks of the medication trial. Bupropion also is effective in treating nicotine dependence in adults; the majority of adolescents with marijuana and other drug abuse also smoke tobacco. More recent research in adults indicates that bupropion may reduce craving and use of other substances of abuse (e.g. methamphetamine, cocaine). It's possible impact on cannabis use disorder (the addiction for which most teens are referred to treatment) has not yet been evaluated. However since all drugs of abuse have a final common pathway leading to addiction via action in the so called brain reward system (ventral tegmental area (VTA), accumbens) -an important secondary aim is to evaluate bupropion's potential impact on craving and use of marijuana (MJ) in addition to its known similar action on nicotine.

NCT ID: NCT00908206 Withdrawn - Alcohol Dependence Clinical Trials

Effects of GSK598809 on Brain Activation in Abstinent Alcoholics

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

This study will compare the effects of GSK598809 and placebo in alcohol dependent volunteers. A placebo is a pill with no drug in it (i.e. dummy drug) but it is made to look exactly like the real drug. Subjects will be given one dose of GSK598809 during one visit and placebo during the other visit. These dosing visits will be at least 1 week apart. The study is randomised, which means that a computer programme will decide by chance (like tossing a coin), the order in which subjects will receive GSK598809 or the placebo, or in other words, whether they will receive GSK598809 or placebo first. The study is blinded, which means the subjects will not know whether they are receiving study drug or placebo first and neither will the doctors at the institute. If necessary for reasons of safety, the study staff can find out exactly what the subject has received. The study will last for approximately 4 weeks but could be up to 6 weeks, depending on length of time between screening and dosing. From screening the subjects will be alcohol-abstinent, they may be put on medication for treatment of withdrawal symptoms and then will have at least 7 days without any medication before beginning the study medication. During the study the subjects will be inpatients at the Central Institute of Mental Health. All subjects will be required to fill out questionnaires, perform behavioural tasks and undergo MRI and functional MRI (fMRI) scans.

NCT ID: NCT00907309 Completed - Alcohol Abuse Clinical Trials

Dental and Medical Office iMET to Reduce Teen Tobacco, Alcohol, and Drug Use

Start date: September 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the project is to improve adolescent behavioral counseling services in healthcare settings with a new Internet/Intranet-based Motivational Enhancement Therapy (iMET) intervention that targets the use of tobacco, alcohol, and other drugs.

NCT ID: NCT00895804 Completed - Clinical trials for Substance-Related Disorders

Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)

Start date: June 2001
Phase: Phase 1
Study type: Interventional

MDMA (3,4-Methylenedioxymethamphetamine, "Ecstasy") produces tachycardia, hypertension, hyperthermia, and other acute adverse effects. Ecstasy use has also been associated with rare cardio- and cerebrovascular complications. The role of beta-blockers in the treatment of cardiovascular and adverse effects of MDMA is unknown.

NCT ID: NCT00891631 Withdrawn - Depression Clinical Trials

Primary Care iSBIRT to Reduce Serious Teen Health Risks

Start date: September 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of the project is to develop and test an internet/intranet-based Screening, Brief Intervention, and Referral to Treatment (iSBIRT) system for adolescents that targets a broad range of serious health-risks and problem behaviors.

NCT ID: NCT00887367 Completed - Clinical trials for Substance Dependence

EtOH Interaction Study

Start date: September 29, 2008
Phase: Phase 1
Study type: Interventional

This study will investigate the possible effects of alcohol in combination with GSK598809 on the central nervous system in 20 healthy male and female volunteers, between 18 and 65 years of age. During 4 separate study periods subjects will receive the following treatment combinations: Alcohol + GSK598809, alcohol + placebo drug, placebo infusion + GSK598809, and placebo infusion + placebo drug. A placebo is a pill or liquid infusion which contains no drug or alcohol; it is a dummy version. Therefore it is administered in the same way that either the study drug or ethanol is depending on which placebo it is. All study drugs are administered in a random order and both the doctor and the participant are not aware of the treatment combination. However treatment combinations will be available at the end of the study or in case of an emergency. GSK598809 is administered orally and alcohol is administered per infusion. The duration of the infusion is 5 hours, during which approximately 75 grams of alcohol is infused, which is comparable to less than one bottle of wine.

NCT ID: NCT00886886 Completed - Clinical trials for Substance-related Disorders

Interaction Between Reboxetine and 3,4-Methylenedioxymethamphetamine: Pharmacodynamics (PD) and Pharmacokinetics (PK)

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

MDMA releases dopamine, serotonin, and norepinephrine in the brain. Serotonin uptake inhibitors have been shown to interact with 3,4-Methylenedioxymethamphetamine (MDMA) and to decrease its psychoactive and cardiovascular stimulant effects. This finding indicates that MDMA acts in part by releasing serotonin through the serotonin uptake site. However, in vitro studies show that MDMA binds more potently to the norepinephrine uptake site that to the the serotonin or dopamine uptake transporter. In addition, norepinephrine uptake site blockers such antidepressant drugs attenuate some of the behavioral effects of MDMA in animals. These preclinical data indicate that norepinephrine may also contribute to the response to MDMA in humans. To test this hypothesis this study evaluates the interacting effects of the selective norepinephrine transporter inhibitor reboxetine on the subjective and cardiovascular stimulant effects of MDMA in healthy volunteers.

NCT ID: NCT00877331 Completed - Clinical trials for Substance-Related Disorders

Brief Intervention in Primary Care for Problem Drug Use and Abuse

Start date: April 2009
Phase: N/A
Study type: Interventional

This study will examine the effectiveness of a brief intervention in a primary care setting to reduce drug use or abuse compared to enhanced care as usual.