Developing a Prescription Opioid Overdose Prevention Intervention in Addictions Treatment
Use of opioid medications for treatment of pain has increased greatly in the U.S., with the average quantity of prescribed opioids increasing 700% in a decade, from ~100 morphine milligram equivalents (MME) per person to ~700 MME per person from 1997 to 2007. There have been concurrent increases in opioid-related adverse outcomes, such as extramedical use, opioid use disorders, and overdose. As a result, there were more unintentional poisoning deaths than deaths due to motor vehicle crashes among adults in 2010 (32,723 vs. 32,640). Additionally, the number of Americans seeking treatment for opioid use disorders has increased; in SAMHSA's Treatment Episode Data Set, prescription opioids were the primary substance of abuse for 142,782 individuals in 2009, compared to 22,637 in 1999, a 530% increase. The specific aims of this project are to: (1) Refine a motivational enhancement prevention intervention for prescription opioid overdose risk reduction and improved witnessed overdose response for at-risk patients in addictions treatment; (2) Conduct a pilot randomized controlled trial comparing the prescription opioid overdose prevention intervention to a supportive educational control condition for patients in addictions treatment in order to: (a) obtain information about the feasibility of randomized controlled procedures; and (b) determine the distribution and variability of the primary (overdose risk behaviors) and mediating/secondary (witnessed overdose response, self-efficacy to reduce overdose risk, knowledge of overdose risk factors and symptom recognition) outcomes; and (3) Determine the distribution and variability in changes in HIV risk behaviors (e.g., reductions in injection of prescription opioids) over follow-up.
NCT02152397 — Drug Overdose
Status: Completed
http://inclinicaltrials.com/drug-overdose/NCT02152397/
Effects of Transcranial Direct Current Stimulation of the Prefrontal Cortex on Cigarette Smoking
Tobacco addiction is treatable with behavioral and pharmacological means, but results are often less than optimal. Transcranial direct current stimulation is a new non-invasive technique that applies weak electrical currents through the skull and has been shown to alter the excitability of certain brain areas. It is currently being tried in disorders where there is abnormal brain excitability, such as epilepsy and depression. A few studies have also been able to diminish drug craving, suggesting that brain excitability might also be altered in drug addiction. This study aims at non-invasively changing the excitability of certain brain areas-a procedure called neuromodulation- in order to help smokers quit smoking more easily.
NCT02146014 — Addiction
Status: Completed
http://inclinicaltrials.com/addiction/NCT02146014/
Characterization Imaging Instruments for Addiction Neuroimaging Assessments
Background: - People with alcoholism have differences in their brains compared with healthy people. People who are dependent on alcohol also perform differently on behavioral tasks. Researchers want to find out more about these differences. They also want to see if these differences are related to DNA. Objective: - To see if differences in brain structure relate to personality and behavior differences in people with and without alcohol dependence. Eligibility: - Adults age 18 and older. Design: - Participants will visit the NIH Clinical Center once during the study. - Participants will be screened with a medical history, EKG, and physical exam. They will give blood and urine samples and undergo a psychiatric interview. - Participants will be asked about their alcohol drinking, to see if they have an alcohol use disorder. - Participants will play three computerized games. Some will play these games inside a magnetic resonance imaging (MRI) scanner. - MRI: strong magnetic field and radio waves take pictures of the brain. Participants lie on a table that slides in and out of a cylinder. They will be in the scanner for about 90 minutes. They may lie still for up to 20 minutes at a time. The scanner makes loud knocking noises. They will get earplugs.
NCT02108080 — Alcoholism
Status: Recruiting
http://inclinicaltrials.com/alcoholism/NCT02108080/
Prefrontal Modulation by Repetitive Bilateral Transcranial Direct Current Stimulation (tDCS) in Crack-cocaine Addicted Inpatients.
In this study, eligible crack-cocaine addicted inpatients recruited from specialized clinics for substance abuse disorder treatment, filling inclusion criteria and not showing any exclusion criteria, were randomized to receive the repetitive (10 sessions, every other day) bilateral dorsolateral Prefrontal Cortex (dlPFC: cathodal left / anodal right) tDCS (2 milliamperes, 3x7 cm2, for 20 min) or placebo (sham-tDCS). Craving to the use of crack-cocaine was examined before (baseline), during and after the end of the tDCS treatment. Based in our previous data, our hypothesis was that repetitive bilateral tDCS over dlPFC would favorably change clinical, cognitive and brain function in crack-cocaine addiction and these would be long-lasting effects.
NCT02091167 — Executive Dysfunction
Status: Completed
http://inclinicaltrials.com/executive-dysfunction/NCT02091167/
The Effect of Aerobic Endurance Training in Patients With Drug Addiction
Physical health does not have a high priority in today's treatment of patients with substance use disorder (SUD) patients have a poor physical health not only due to injuries related to the substance abuse, but also because of the lifestyle that addiction causes. There are today few studies that provide information about SUD patients' physical health. One of the project's aims is to document the physical health of SUD patients in treatment, using objective measures. After completion of various physical tests, an 8 week period of high intensity aerobic training intervention will follow. It will be investigated if the SUD patients are able to engage and participate throughout the whole training intervention, to what degree the participants improve their physical health and the effect of physical health improvement on substance abuse treatment.
NCT02017821 — Substance-Related Disorders
Status: Completed
http://inclinicaltrials.com/substance-related-disorders/NCT02017821/
Establishing and Eliminating Cue-drug Associations in Human Cocaine Addiction
We will develop a procedure for conditioning cue-cocaine associations in human drug users. Next, we will reactivate that learning and intervene pharmacologically to prevent the reconsolidation of cue-drug memories. We hypothesize that a combined behavioral and pharmacological approach will have significant potential for persistently inhibiting relapse.
NCT01978457 — Cocaine Dependent Subjects
Status: Terminated
http://inclinicaltrials.com/cocaine-dependent-subjects/NCT01978457/
Repetitive Transcranial Magnetic Stimulation (rTMS) in Alcohol Dependent Patients: a Mechanistic Study.
The investigators hypothesize that repetitive transcranial magnetic stimulation (rTMS) on the right side of the head will make craving towards alcohol less severe in recently detoxified alcohol addicted patients. Although there are successful treatment option to detoxify patients form their alcohol use, many patients tend to relapse. This relapse is mainly caused by a high level of (uncontrollable) craving towards alcohol. This aspect of addiction is with the existing options hard to treat, there is a great need of new successful treatment modalities. rTMS is a FDA approved treatment method for depression. Recently some small scale studies have shown promising results on rTMS in the treatment of addiction. In this study the investigators focus on alcohol addiction since it is the addiction with the highest morbidity and mortality in the Netherlands.
NCT01973127 — Alcohol Addiction
Status: Not yet recruiting
http://inclinicaltrials.com/alcohol-addiction/NCT01973127/
Multimodal Imaging of Progesterone/Neurosteroid Effects in Nicotine Addiction
Male and female smokers were recruited to undergo 2 phases of smoking cessation. Each phase was 4 days long and involved 3 brain-imaging scans, blood draws and an intervention involving progesterone or a matched placebo.
NCT01954966 — Nicotine Dependence
Status: Completed
http://inclinicaltrials.com/nicotine-dependence/NCT01954966/
The Impact of Genetic Variation In Nicotinic Cholinergic Receptors on Functional Brain Networks Underlying Addiction Susceptibility
Background: - The risk for becoming addicted to drugs varies from person to person, even among those using similar drugs in a similar way. Researchers do not fully understand why some people become addicted to drugs and others do not. Studies suggest that under certain life circumstances, some genes may increase the risk for addiction. This study will use genetic information, computer tasks, magnetic resonance imaging (MRI), and other tests to see what brain networks may be related to drug addiction. Objectives: - To better understand brain networks that may be related to susceptibility to drug addiction. Eligibility: - Healthy non-smoking volunteers between 18 and 55 years of age. Design: - This study will have one screening visit and four all-day study visits. For male participants, the visits will be about 7 days apart over 5 to 7 weeks. Female participants will have the visits scheduled to coordinate with their menstrual cycle. - This study involves small doses of three approved drugs: two oral dopamine drugs and a nicotine patch. For each scanning session, participants will have three study drugs. However, only one pill or patch will be the real drug; the other two will be placebos. Some participants may have only placebos during a visit. - Participants will be screened with a physical exam and medical history. Blood and urine samples will be taken. Other tests will be given to ensure that participants are not smoking or using drugs while they are in the study. - During the all-day scanning visits, participants will receive two pills and one patch in the morning and they will be trained on simple computer tasks. In the afternoon, participants will have MRI scans and we will measure their brain activity while they rest and while they perform computer tasks in the scanner. Participants will also answer questionnaires during the scanning visits.
NCT01924468 — Nicotine Dependence
Status: Completed
http://inclinicaltrials.com/nicotine-dependence/NCT01924468/
Addiction Treatment Dropout Prevention - Impact of Online Patient Feedback (OQ-45.2) to Therapist
Dropout represents one of the largest problems in substance abuse treatment. International and Nordic research show that only 20 - 40 % of substance abusers complete treatment as intended. At the same time, one of the most consistent factors of favourable post-treatment outcome is treatment completion. In spite of the serious and continuous challenge dropout represents the phenomena is not well understood and there is a need to explore more of the factors that influence dropout and how it can be counteracted. As also stated: "…effective methods for reducing the problem of dropouts from treatment is one more area in need of further research" (NOU 2003:4, s 77). For the general field of mental health one of the most important innovations involves providing therapists with patient feedback about their progress. The most well-established and widely researched feedback system is the Outcome Questionnaire (OQ-45.2). The system has been shown to improve treatment outcomes, including reduced treatment dropout and length of treatment, but the system is yet to be utilized with a substance abusing patient group. The aim of the present study is to examine the usefulness of OQ-45.2 with substance abusing patients.
NCT01891045 — Drug Abuse
Status: Completed
http://inclinicaltrials.com/drug-abuse/NCT01891045/