Cocaine Withdrawal and Pharmacotherapy Response
Cocaine DependenceOpiate DependenceA total of 120 male and female opioid dependent cocaine users will participate in this study. This study will be a 8-week double-blind, placebo controlled study examining the dose-dependent effects of carvedilol (up to 50 mg/day) in methadone stabilized patients. The design will have two phases: 1) a four-week "treatment " phase; and 2) a 4 week " taper and detoxification or transfer" phase. Subjects will be cocaine users who are on stable doses of methadone (60 to 140 mg/day). Carvedilol dose will be increased from 12.5mg/day to the target dose of either 25 or 50 mg/day as tolerated. At the end of the treatment-phase, subjects will undergo detoxification from methadone over a 2 to 4-week period based on an individual's needs, and they will concurrently be tapered off carvedilol.
Abuse Liability of Suboxone Versus Subutex
Opioid-related DisordersThe study is designed to compare the abuse liabilities of intravenous buprenorphine and buprenorphine/naloxone in individuals who are physically dependent on sublingual buprenorphine. We hypothesize that the abuse liability of buprenorphine/naloxone is lower than that of buprenorphine alone.
Phase IIa Study of AV411, a Glial Activation Inhibitor, for Opioid Withdrawal
Opioid-Related DisordersRepeated use and/or abuse of opioid medications is generally associated with a characteristic withdrawal syndrome that develops after cessation of drug administration. The present study is designed to evaluate the effectiveness of AV411 to alter opioid-induced withdrawal symptoms.
Reinforcing Effects of Brief Exposures to Nitrous Oxide - 8
Opioid-Related DisordersSubstance-Related DisordersThe purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine reinforcing effects of brief exposures to nitrous oxide in healthy volunteers.
Effects of Alcohol History on Effects of Sevoflurane and Nitrous Oxide - 13
Alcohol-Related DisordersOpioid-Related Disorders1 moreThe purpose of this study is to evaluate the effects of alcohol history on the subjective and reinforcing effects of sevoflurane and nitrous oxide in healthy volunteers. All subjects underwent psychomotor testing during 4 sessions of placebo, drug/placebo, and choice of intervention.
START NOW in the Treatment of Opioid Addicted Individuals
Opioid Use DisorderThis investigation involves a partially randomized clinical trial examining the effectiveness of combining buprenorphine/naloxone MAT with START NOW, a skills-based psychosocial intervention modified specifically for the ambulatory substance use disorder (SUD) patient population. START NOW is an integrated evidence-informed model based on an adapted form of dialectical behavior therapy (DBT), a type of cognitive behavior therapy (CBT) with promising indications for treating SUD as it targets impulsive and self-destructive behaviors. Furthermore, START NOW combines CBT, the most widely used evidence-based psychosocial intervention for treating mental disorders, with motivational interviewing, which in clinical trials has been shown to be an effective technique for engaging patients with SUD. In addition to tracking clinical outcomes such as abstinence rates through weekly urine drug screens, this investigation will use: clinician assessments of disease severity, researcher-evaluated tests of delayed discounting (DD) and demand tasks, and self-report surveys assessing impulsivity, aggression, interpersonal skills, and other measures to capture the patients' sense of progress in treatment in regards to their substance use, health, lifestyle, and community. By using DD and functional magnetic resonance imaging (fMRI), the identification of the neural correlates of START NOW treatment response will begin to elucidate the mechanisms of START NOW's effects and more. This investigation's outcome measures may not only compare the effectiveness between START NOW and treatment-as-usual (TAU), but also provide a more realistic, holistic view of patients and their well-being throughout the recovery process. DD will be performed by both START NOW group members and TAU group members at their group therapy meetings as per protocol. Additionally, START NOW group members randomized and consented to have an fMRI will also perform DD before the scan is initiated.
A Randomized Trial of Interim Methadone and Patient Navigation Initiated in Jail
Opioid Use DisorderThe purpose of this study is to determine which of three approaches started in jail is more effective in treating opioid use disorder: (1) methadone treatment without counseling (termed interim methadone) coupled with case management (termed patient navigation); (2) interim methadone without patient navigation; (3) or an enhanced treatment as usual including opioid detoxification, overdose prevention and drug treatment information and referral.
Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled...
Narcotic AbuseOpioid-related Disorders2 moreThis was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine sulfate CR tablets and placebo in healthy male and female, non-dependent, recreational opioid users. An appropriate dose of morphine sulfate CR (i.e., 30 mg, 60 or 90 mg) was to be selected during Part A of the study (Dose Selection Phase). Each subject participated in the study for up to (approximately) 16 weeks and was confined in the clinic for a total of up to 12 nights.
Remote Observed Dosing to Increase Suboxone Compliance
Opiate DependenceThe goal of this project is to test the feasibility, acceptability, and preliminary efficacy of using remote compliance monitoring in buprenorphine (Suboxone®) treatment for opiate dependence. To that end, 10 opiate dependent subjects will be recruited through the University of Pennsylvania's Treatment Research Center, an outpatient substance abuse treatment facility. All subjects will receive buprenorphine (Suboxone®) (16 mg/day, adjusted as needed according to individual requirements).
Addressing Origins of the Opioid Epidemic by Improving Prescribing for Opioid-Naive Patients
Opioid UseOpioid-Related Disorders2 moreRisk of long-term opioid dependence increases with initial opioid dose/duration, but despite recent Centers for Disease Control and Prevention (CDC)-endorsed minimum doses for initial opioid prescription, primary care providers are likely to overprescribe. In this quality improvement project, primary care departments at Weill Cornell and the Institute for Family Health (federally qualified health center in New York City) will implement an unobtrusive "nudge" in their electronic prescribing software to promote the CDC-endorsed low doses for all opioids. In the evaluation, we will employ a quasi-experimental design with rigorous interrupted time series analysis methods to assess the effect of the "nudge" on prescribing rates. The analysis will be performed at the provider level, with deidentified physician data and a limited data set (fully deidentified except for date of prescription) of patient-level data.