Active clinical trials for "Substance-Related Disorders"

Treatment studies have demonstrated that current smoking cessation techniques are less effective for women. The purpose of this study is to determine the role that gender plays in the effectiveness of nicotine replacement therapy. In addition, the purpose of this study is to determine whether men and women differ in their response to smoking-related stimuli (e.g., taste or smell of a lit cigarette). Conclusions drawn from this study may help to improve cessation interventions for all smokers, particularly women.

The purpose of this study is to determine the effects of combined alcohol and nitrous oxide intake on mood, psychomotor performance, and the pain response in healthy volunteers.

The purpose of this study is to examine the subjective, psychomotor, and reinforcing effects of combined alcohol and nitrous oxide intake in healthy volunteers.

The United States is in the midst of an opioid crisis. Over-prescription of opioid analgesic pain relievers contributed to a rapid escalation of use and misuse of these substances across the country. In 2016, more than 2.6 million Americans were diagnosed with opioid use disorder (OUD) and more than 42,000 have died of overdose involving opioids. This death rate is more than any year on record and has quadrupled since 1999 (1,2). Leveraging the potential of available data bases and health IT technologies may help to combat opioid crisis by targeting various aspects of the problem ranging from the prevention of opioid misuse to OUD treatment. NIH through NIDA solicits the research and development of data-driven solutions and services that focus on issues related to opioid use prevention, opioid use, opioid overdose prevention or OUD treatment. In this project, We The Village, Inc. will address a need to prepare Concerned Significant Others (CSOs) to best use their influence over the trajectory of a loved one's OUD. CSOs are motivated to help, make majority of treatment decisions and payments and have influence over treatment entry and thus, impact the trajectory of an OUD. The project goal is to develop digital delivery of Community Reinforcement And Family Training (CRAFT) methodology, an empirical family behavioral intervention to improve outcomes around treatment entry, family functioning and substance use.

Youth To Text or Telehealth for Engagement in HIV Care (Y2TEC) is a randomized control pilot to assess the feasibility and acceptability of delivering a targeted problem-solving intervention to youth ages 18-29 living with HIV (YLWH) for improving HIV care engagement, mental health, and decreasing substance use. The intervention will be delivered to participants in two condition groups in remote telehealth sessions delivered via video-conference over 4 months. Participation in the study will last about 8 months. The investigators hypothesize that the Y2TEC intervention will be feasible and acceptable for YLWH, and will result in improved HIV clinical outcomes. If feasible and acceptable, it can be scaled up for a multi-site randomized clinical trial and ultimately offered in the clinical care of YLWH.

The trial comprises an Enrollment Visit, a Qualification Phase, a Treatment Phase (including 3 treatment periods), a Final Examination, and a Follow-up Phone Call. The Qualification Phase includes a naloxone challenge test (to verify that participants are not opioid-dependent) and a drug discrimination test (to determine whether or not participants are able to distinguish intranasally administered active drug from placebo). Participants will be randomized to receive a single intranasal dose each of oxycodone active pharmaceutical ingredient (API) and matching placebo in a double-blind manner. The total mass of each single dose will be 30 milligrams. Participants who successfully complete the Qualification Phase are eligible to be included in the Treatment Phase. During the Treatment Phase, participants will receive test product, comparator, and placebo following a randomized, double-blind, double-dummy, 3-way crossover design. Participants will receive a single intranasal dose of each of the treatments (combined doses of investigational medicinal product {IMP}) on Day 1, Day 4, and Day 7 of the Treatment Phase. A single dose of a treatment is defined as insufflation of single doses of the 2 applicable IMPs in quick succession. The 2 applicable IMPs must be insufflated in the following pre-defined order. Oxycodone API or placebo to match oxycodone API must always be insufflated first. Oxycodone immediate release (IR) abuse-deterrent formulation (ADF) or placebo to match oxycodone IR ADF must always be insufflated second. The total mass of each single dose of treatment will be 570 milligrams.

Tobacco regulatory policies can have unanticipated consequences; therefore, methods that would permit prospective estimates of the effects of potential tobacco regulations are necessary for the development of tobacco regulatory science. The goal of this project is to experimentally assess how smokers purchase and consume reduced-nicotine cigarettes. In experiment 1, we will investigate how purchasing/consuming reduced-nicotine cigarettes is related to nicotine content and absorption. In experiment 2, we will investigate how purchasing/consuming changes when other nicotine products are available in an experimental marketplace setting. The proposed projects can directly inform tobacco regulation by providing estimates of the real-world effects of novel policies.

The purpose of this study is to evaluate the impact of (1) Implementation Facilitation (IF) on rates of provision of Emergency Department (ED)-initiated buprenorphine/naloxone (BUP) treatment with referral for ongoing medication-assisted treatment (MAT) and the (2) effectiveness of IF on patient engagement in formal addiction treatment at 30 days.

The proposed 2-week, double-blind, crossover, proof of concept study aims to measure and manipulate core neurochemical (i.e., dysregulated brain GABA/glutamate homeostasis) and neurobehavioral (i.e., elevated impulsivity) dysfunctions characteristic of individuals with cannabis use disorder (CUD) and Bipolar Disorder (BD), using a medication that has been shown to increase cortical GABA (i.e., gabapentin) levels in past research, and to evaluate medication-related changes in response inhibition (go no-go) and cannabis cue reactivity functional Magnetic Resonance Imaging tasks, as well as cannabis use, mood symptoms (including anxiety and sleep), and impulsivity in individuals with CUD+BD.

In Phase I of this SBIR project, 3C Institute (3C) developed a working prototype of an innovative computer-based coping skills educational program for adolescent substance abuse treatment completers. For Phase I, 3C developed and tested two customizable intelligent educational modules to teach coping skills in order to help adolescents avoid relapse, along with a brief instructional game for each segment. The Phase I prototype also included an online Parent Guide to inform parents about the uses and benefits of the product. Phase I R&D provided strong support for the quality and value of the prototype as well as the viability of the proposed educational package and its promise for preventing substance abuse relapse with adolescents. Phase I results supported excellent quality of the product through high ratings of quality, appeal, and value. High feasibility and usability was also demonstrated through high ratings for ease of use, usability, and potential effectiveness. The goal of this Phase II SBIR project is to modify and expand the relapse prevention program developed in Phase I in response to customer feedback and to evaluate the efficacy of the full program with an RCT pilot clinical study. This product will be an adaptable software program for aftercare therapy. In Phase II, the investigators will build on the Phase I findings to modify and extend the existing content and develop the full program, which will include: an introductory module as well as interactive lessons and skill-building games for five coping skills modules. The Phase II product will also include a HelpCenter to support sustained, quality use of the product during commercialization.