Clinical Trials

Combining Neuro-Imaging and Non-Invasive Brain Stimulation for Clinical Intervention in Opioid Use Disorder

Project Description

The overarching goal of this project is to expand the traditional expertise in non-invasive neuromodulation at the University of Minnesota towards developing novel paired-neuromodulation approaches using transcrancial direct current stimulation (tDCS) for new addiction treatments that support long-term abstinence. This study will investigate whether the pairing of dorsolateral prefrontal cortex (DLPFC) stimulation and cognitive training can enhance functional connectivity between DLPFC and nucleus accumbens (NAcc). We have identified higher functional connectivity between DLPFC and NAcc in alcoholics that have successfully maintained abstinence for extended periods of time (7 years). This paired-neuromodulation approach can potentially be used as a therapeutic intervention to decrease substance use probability in addiction (e.g. opioid use disorder). The long term goal is to develop new addiction treatments that support long-term abstinence in opioid use disorder. The overall objective of this proposal is to enhance functional connectivity between DLPFC and NAcc as a therapeutic intervention to enhance cognition and reduce substance use rates in opioid use disorder.


 

Bupropion for the Prevention of Postpartum Smoking Relapse

Project Description

This two-arm, double-blind, placebo-controlled randomized clinical trial will enroll pregnant women who quit smoking after learning they were pregnant and are motivated to stay abstinent postpartum. Participants will be randomized to receive extended-release bupropion (active 300mg or placebo once daily beginning 4 to 10 days postpartum to 12 weeks post-randomization). All participants will complete the same data collection procedures (e.g., biological sample collection for hormone and cotinine analysis and completion of validated questionnaires) at baseline (gestational week 36), weekly from 4 to 10 days postpartum through 12 weeks post-randomization and at weeks 12, 24, 36 and 52 post-randomization.


 

Neuromodulation and Cognitive Training in Opioid Use Disorder

Project Description

Patients will receive 20 minutes of continuous stimulation of either active or sham transcranial direct current stimulation every day for five consecutive days. This will allow investigation to whether the pairing of dorsolateral prefrontal corex stimulation and cognitive flexibility training can enhance functional connectivity between dorsolateral prefrontal corex and nucleaus accumbens, assisting with treatment for opioid use disorder.


 

Psychophysiological Stress Reactivity as a Determinant in Co-occurring Alcohol Use and Anxiety Disorders: Diagnosis and Alcohol Use Outcomes

Project Description

Comorbid AUD+AnxD is a significant barrier to successful AUD treatment. Converging evidence implicates overlap in dysregulation of systems governing stress response (HPA, ANS, CNS) for symptom development in AUD and AnxD. However, this must be systematically demonstrated in comorbid AUD+AnxD. We will assess markers of multi-system biological stress regulation (at rest and in response to laboratory challenge) in alcohol use disorder (AUD) inpatients with and without co-occurring anxiety disorder (AnxD), as well as those with AnxD who do versus do not receive a cognitive behavioral treatment that specifically targets comorbid AUD-AnxD. Laboratory measures include 1) cortisol (to assess the hypothalamic–pituitary–adrenal axis system [HPA] function; 2) heart rate variability (to assess autonomic nervous system [ANS] function), and 3) threat-potentiated startle (to assess central nervous system [CNS] function). Laboratory assessments will occur at the following times: 1) shortly after AUD treatment admittance (Visit 2: Pre-Treatment), 2) immediately following the 4-week AUD treatment (Visit 3: Post-Treatment), 3) 1 month following AUD treatment (Visit 4: 1-Month Follow-Up), and 4) 4 months following AUD treatment (Visit 5: 4-Month Follow-Up). Self-reported alcohol intake will be assessed at baseline as well as at the 1- and 4-Month Follow-Ups to determine whether laboratory stress measures predict treatment outcomes. A single laboratory assessment of healthy controls will serve as a normative reference for characterizing patient laboratory responses in terms of dysregulation and re-regulation.


 

Neuromodulation and Cognitive Training for Substance Use Disorders

Project Description

The relapsing nature of Stimulant use disorder is a major obstacle to successful treatment. About 70% of those entering treatment will relapse within one year. To improve treatment outcome, new interventions targeting the underlying brain biomarkers of relapse vulnerability hold significant promise in reducing this critical public health problem. The overarching goal of this project is to expand the traditional expertise in non-invasive neuromodulation at the University of Minnesota towards developing novel paired-neuromodulation approaches using transcranial direct current stimulation (tDCS) for new addiction treatments that support long-term abstinence. This study will allow us to investigate whether the pairing of dorsolateral prefrontal cortex (DLPFC) stimulation and cognitive training can lead to improved treatment outcomes as it pertains to executive functioning and maintenance of abstinence. This paired-neuromodulation approach can potentially be used as a therapeutic intervention to decrease relapse probability in addiction. The long term goal is to develop new addiction treatments that support long-term abstinence.


 

Impact of low nicotine cigarette messaging on risk perceptions and hypothetical tobacco and nicotine product choices.

Project Description

The purpose of this research is to evaluate the effects of low nicotine content cigarette (LNC) educational messaging on perceptions of low nicotine cigarettes, tobacco/nicotine product choice preferences (hypothetical), LNC cigarette subjective ratings, and LNC cigarette abuse liability among adult smokers.


 

PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Primary Care Providers (PRINCE)

Project Description

The objective of this research is to assess the effects of electronic health record (EHR)-based decision support tools on primary care provider (PCP) decision-making around pain treatment and opioid prescribing. The decision support tools are informed by principles of "behavioral economics," whereby clinicians are "nudged," though never forced, towards guideline-concordant care.


 

PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Opioid-Naive Population (PRINCE)

Project Description

The objective of this research is to assess the effects of electronic health record (EHR)-based decision support tools on primary care provider (PCP) decision-making around pain treatment and opioid prescribing. The decision support tools are informed by principles of "behavioral economics," whereby clinicians are "nudged," though never forced, towards guideline-concordant care.


 

PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Current Opioid-User Population (PRINCE)

Project Description

The objective of this research is to assess the effects of electronic health record (EHR)-based decision support tools on primary care provider (PCP) decision-making around pain treatment and opioid prescribing. The decision support tools are informed by principles of "behavioral economics," whereby clinicians are "nudged," though never forced, towards guideline-concordant care.


 

Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace (CENIC2 Project 1)

Project Description

This project will examine the impact of very low nicotine content (VLNC) cigarettes in a complex tobacco and nicotine product marketplace. We will compare the number of cigarettes smoked and cigarette-free days in an experimental marketplace that contains VLNC cigarettes versus normal nicotine content (NNC) cigarettes.


 

Adaptive Interventions for Smoking Cessation in Lung Cancer Screening Programs

Project Description

In this sequential, multiple assignment, randomized trial (SMART) current smokers who are eligible for lung cancer screening will be identified using the electronic medical record at the University of Minnesota and Minneapolis VA (N=1000). All participants will receive 8 weeks of evidence-based first-line smoking cessation treatment. Participants will be eligible for three potential randomizations during one year of smoking intervention: 1) to timing of identifying early response to treatment at 4 vs. 8 weeks (all participants), 2) to telephone-based tobacco longitudinal care (TLC) vs. TLC plus pharmacist-administered Medication Therapy Management (incomplete responders to first-line treatment, Primary Aim), and 3) to monthly TLC contact vs. quarterly TLC contact (complete responders to first-line treatment, Secondary Aim). The primary outcome will be 6 months of prolonged abstinence measured 18 months after the beginning of treatment.