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Drug Dependence clinical trials

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NCT ID: NCT01036126 Completed - Drug Dependence Clinical Trials

Automatic Versus Evaluative Components of Cue Reactivity

Start date: August 12, 2003
Phase: N/A
Study type: Observational

Background: - Relapse to drug abuse often happens in the presence of stimuli that are associated with previous drug use, also known as cues. Drug-taking behavior appears to be partly controlled by such cues. Some research suggests that cue-induced craving states are responsible for drug use and relapse, but other research suggests that cues can control drug taking without conscious craving or even awareness. Researchers are interested in using functional magnetic resonance imaging (fMRI) to study how individuals respond to drug-related cues and how these cues affect craving on a conscious or unconscious level. Objectives: - To determine how drug-related stimuli (cues) affect thinking, information processing, and body reactions in current drug users. Eligibility: - Individuals between 18 and 50 years of age who are dependent on either tobacco or crack-cocaine, or are healthy volunteers who are not dependent on either drug. Design: - The study will require two sessions, a training session and a testing session, that will take place within 48 hours of each other. Between the two test sessions, participants may not consume alcohol, tobacco, or illegal drugs, and must restrict caffeine consumption. - During the first session, participants will complete questionnaires about tobacco/cocaine use and craving, and will be trained on the tasks to be performed in the MRI scanner. - During the second session, participants will perform concentration tasks and look at pictures, some of which will be tobacco/cocaine related. Body reactions such as heart rate, pupil dilation, and sweating will be measured during this session. Some participants will have actual MRI scanning, while others will have mock MRI scanning. - After the MRI session, participants will complete questionnaires about craving and responses to the scan.

NCT ID: NCT00975416 Terminated - Drug Dependence Clinical Trials

Oxytocin and Cognitive Behavioral Therapy in Drug Dependence

Start date: November 2008
Phase: Phase 4
Study type: Interventional

Background: - The therapeutic alliance between therapist and patient may contribute to favorable outcomes in all types of psychotherapy, including cognitive behavioral therapy (CBT) for drug dependence. Oxytocin, a hormone and neurotransmitter, has been shown to increase trust in other people and may reduce stress and improve comfort in social situations by decreasing the sensation of social anxiety. Researchers are interested in determining if oxytocin can improve the outcomes of therapy for drug dependence by strengthening perceived levels of trust between therapist and patient. Objectives: - To determine whether oxytocin enhances the therapeutic alliance and treatment retention for CBT for drug use. Eligibility: - Individuals between 18 and 65 years of age who are healthy volunteers with no history of drug abuse, participants in outpatient or inpatient treatment programs for cocaine use, methadone-dependent participants in a treatment program, or non-treatment-seeking cocaine users. Design: - Participants in each treatment arm who comply with the study requirements will be randomly assigned to receive one dose of oxytocin or placebo approximately 1 hour before each weekly CBT session. - The outpatient treatment intervention will be 12 weeks of weekly individual CBT. The inpatient treatment intervention will be 6 weeks of twice-weekly individual CBT sessions. Sessions will be audiotaped. Participants and counselors will be told that the sessions are to be taped. - During treatment, participants will provide urine and breath samples under staff observation. Participants will also complete questionnaires about mood and mental health, provide other samples as required, and participate in computerized psychological testing as directed by researchers.

NCT ID: NCT00882648 Completed - Pregnancy Clinical Trials

The Effect of Fetal Gender on Maternal Substance Abuse Treatment

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

Previous studies by this team of investigators has determined that male infants are more likely to display more severe neonatal abstinence syndrome (NAS) as a result of maternal opioid use during pregnancy (Jansson, 2007)and there is appears to be a gender-related biologic vulnerability to NAS expression (Jansson, 2009, submitted). The proposed study explores the relationship between fetal gender and substance abuse treatment outcomes among a population of women in comprehensive substance abuse treatment to explore the possibility of a psychosocial vulnerability among drug exposed male fetuses as opposed to female fetuses. Women in substance abuse treatment are a group at high risk for current exposure to violence, usually at the hands of significant others, and having a history of sexual abuse as a child, usually resulting from contact with a male family member. Therefore, they often have difficult relationships with men. At the Center for Addiction and Pregnancy (CAP), a 2006 study revealed that among a group of 715 pregnant women, reports of the exposure to violence was very high. Their rates of lifetime abuse ranged from 72.7% for physical abuse to 44.5% for sexual abuse. Rates of abuse remained high during their current pregnancy, ranging from 20% for physical abuse to 7.1% for sexual abuse (Velez, 2006). The abuse was very often at the hands of partners or other male family member perpetrators. We hypothesize that women carrying male fetuses will be less likely to remain complaint in drug treatment or abstinent from illicit drug use, while women carrying female fetuses may be more likely to remain drug abstinent and treatment compliant. If supported, this theory has the potential to inform fetal gender specific treatment for pregnant drug dependent women. Additionally, we seek to support the previously documented link between male gender and more severe expression of NAS, and explore the relationship between other maternal prescribed drug use (i.e. psychotropic medications) and severity of NAS expression.

NCT ID: NCT00876941 Completed - Drug Abuse Clinical Trials

Assessing Screening Plus Brief Intervention's Resulting Efficacy (ASPIRE) to Stop Drug Use

ASPIRE
Start date: April 2009
Phase: Phase 3
Study type: Interventional

The objective of this study is to test whether screening and brief intervention for drug use among primary care patients leads to improved drug-related outcomes (such as decreased drug use and consequences).

NCT ID: NCT00798538 Completed - HIV Clinical Trials

Integration of Buprenorphine Into HIV Clinical Settings - Primary Care Model (PCM)

BELIEVE
Start date: August 2005
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the feasibility, cost and effectiveness of interventions designed to integrate buprenorphine treatment for opioid dependence into HIV primary care in ten HIV care centers in the U.S. In the site led by Dr. Altice, we compare two models of providing HIV care and buprenorphine treatment. Assignments are based on participants' city of residence. In the onsite (integrated care) model, participants receive buprenorphine, substance abuse counseling and HIV care at one location: the Waterbury Hospital Infectious Disease Clinic. In the off-site model (non-integrated care) buprenorphine induction, substance abuse counseling, and HIV care will be provided at separate locations: the Community Health Care Van (CHCV), the Yale AIDS Program, and patients' own HIV providers, respectively. Data is collected from interviews with participants, reviews of medical records, and surveys and interviews with clinicians.

NCT ID: NCT00706901 Completed - Alcohol Dependence Clinical Trials

Impact of Group Motivational Interviewing and In-Home-Messaging-Devices for Dually Diagnosed Veterans

GMI-IHMDs
Start date: May 3, 2010
Phase: N/A
Study type: Interventional

Two approaches for providing evidence-based substance abuse treatment (EBT), group motivational interviewing (GMI) and the In-Home-Messaging-Device (IHMD), are interventions that have the characteristic ability for increasing accessibility to evidence-based treatment among patients with substance use problems and are proposed for investigation. GMI is based on motivational interviewing, an intervention that has shown consistent significant effects in promoting treatment retention and reduced substance use among individuals with substance use disorders, and is delivered in a group format. IHMD is a user-friendly computerized Tele-mental Health communication tool that allows interaction through the telephone line between a Veteran and the health care provider in an individual's home or residential placement. The current proposal aims to determine whether GMI and IHMD lead to a significantly greater increase in treatment engagement and reduction in alcohol use compared to a treatment control condition (TCC) among Veterans with a substance use problem and a co-existing psychiatric disorder.

NCT ID: NCT00675532 Withdrawn - Drug Dependence Clinical Trials

Testing a Primary Care Model for the Treatment of Opioid Dependence Using Long-acting Injectable Naltrexone (Vivitrol).

Start date: May 2011
Phase: N/A
Study type: Interventional

In opioid dependent patients treated with long-acting injectable naltrexone (Vivitrol ®), we will compare the efficacy of a primary care model of counseling (Condition 1) versus individualized cognitive-behavioral psychotherapy (Condition 2) for the treatment of opioid dependence. Treatment will last 12 weeks, and participants will be given 380mg of naltrexone per injection (3 injections in total; each lasting 4 weeks). Primary outcomes will be 1) percent of opioid negative urines and 2) treatment compliance as measured by attendance and time in treatment. Secondary outcomes are opiate craving, opiate withdrawal symptoms, perceived stress scores, severity of addiction problems, and patient satisfaction. Findings will elucidate whether injectable, long-acting naltrexone would be safe and effective in a primary care setting where medication would be administered in the absence of traditional cognitive-behavioral psychotherapy and indicate whether cognitive-behavioral psychotherapy adds to treatment effects above and beyond primary care counseling. If positive, this small controlled study will provide effect size estimates for a larger trial to assess Vivitrol ® in a primary care setting.

NCT ID: NCT00605033 Completed - Opiate Dependence Clinical Trials

A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)

Start date: March 2008
Phase: Phase 4
Study type: Interventional

Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone.

NCT ID: NCT00604188 Completed - Opiate Dependence Clinical Trials

A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users (P05042)(COMPLETED)

Start date: February 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the acceptability and safety of Suboxone in heroin users as a replacement therapy for opioid dependency by comparing the clinical response of participants who are inducted directly onto Suboxone with that of participants who are inducted first to Subutex and then transferred to Suboxone.

NCT ID: NCT00593463 Completed - Drug Dependence Clinical Trials

Drug Discrimination in Methadone-Maintained Humans Study 1

OMDD1
Start date: September 2006
Phase: Phase 1
Study type: Interventional

This study involves giving psychoactive drugs intramuscularly (injected into the muscle of the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the difference between one drug and another, as well as measuring the effects of the drugs on mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each subject will receive 2-4 of the listed interventions.