Sequential Trial of Adding Buprenorphine, Cognitive Behavioral Treatment, and Transcranial Magnetic Stimulation to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain (ACTION)

Date Added
January 2nd, 2024
PRO Number
Pro00130123
Researcher
Kelly Barth

List of Studies


Keywords
Drug Studies, Pain, Psychiatry, Substance Use
Summary

This study aims to investigate innovative approaches to managing chronic pain and opioid use. This study consists of two phases, each offering different treatment options. Participation is voluntary.

This study will sequentially evaluate three novel and scalable interventions for at-risk individuals on long term opioid therapy for chronic pain: (1) low-dose transdermal buprenorphine initiation without a period of opioid withdrawal; (2) a brief Cognitive Behavioral Intervention for pain (CBI); and (3) transcranial magnetic stimulation by examining standardized repeated measures of clinical outcomes at baseline, during treatment, and at follow-up.

Phase 1:
In this initial phase, all participants will have a 1-week open-label trial of buprenorphine (worn as a patch on the arm, shoulder or upper-back). This trial aims to assess the safety and effectiveness of buprenorphine in managing chronic pain and opioid use. During this phase, participants will have the opportunity to experience the effects of buprenorphine under close monitoring.

Phase 2:
After completing Phase 1, participants will have the opportunity to choose their next course of treatment. They can decide to continue with buprenorphine, and undergo a 1-week trial of either real buprenorphine or a placebo (an inactive substance). They will be randomly assigned to receive either real or placebo buprenorphine. If participants respond well to buprenorphine treatment, they may continue the medication under the care of their physician.

Alternatively, participants can explore an alternative treatment called repetitive transcranial magnetic stimulation (rTMS) in Phase 2. If they opt for rTMS, they will receive either real rTMS or a sham version interspersed with cognitive-behavioral therapy for pain. Participants will be randomly assigned to receive either real or sham rTMS.

In both phases, participants will receive close monitoring and attend regular study visits to assess safety and progress. Throughout the study, they will be asked to complete questionnaires about pain, functioning and opioid use, undergo physiological monitoring and blood samples will be collected at specific points.

It's important to note that there are potential risks associated with the study medication, such as difficulty sleeping, nausea, and dizziness. Additionally, for the rTMS arm, there is risk of mild headache, pain at the stimulation site, and there may be unknown risks related to the brain stimulation.

Participants' experience in Phase 1 will involve an open-label trial of buprenorphine, and participants' decisions in Phase 2 will determine the treatment path. While the effectiveness of these treatments is uncertain, participants will receive thorough monitoring throughout the study, and have the option to withdraw at any time. Improvement in participant symptoms is possible but not guaranteed.

Institution
MUSC
Recruitment Contact
Georgia Mappin
843-764-7316
mappin@musc.edu

Evaluation of a Choice Drinking Bar-Laboratory Paradigm for Individuals with Bipolar Disorder

Date Added
November 7th, 2023
PRO Number
Pro00131339
Researcher
Will Mellick

List of Studies


Keywords
Alcohol, Mental Health, Substance Use
Summary

This study will evaluate the associations and interactions between bar-lab/naturalistic drinking variables with participant characteristics in individuals with bipolar disorder and alcohol use disorder. This study includes 4 study visits over approximately 1 week. Questionnaires and clinical interview measures will be completed at study visits.

Institution
MUSC
Recruitment Contact
Sara Hix
843-792-0572
hixs@musc.edu

The impact of cannabis and tobacco/nicotine product co-use in young adults: Prospective cessation evaluation and substitution

Date Added
September 15th, 2023
PRO Number
Pro00131124
Researcher
Erin McClure

List of Studies


Keywords
Smoking, Substance Use
Summary

The goal of this project is to better understand the relationship between tobacco/nicotine and cannabis using behavioral economics during a tobacco/nicotine quit attempt. All participants will receive tobacco/nicotine cessation treatment (smoking and/or vaping treatment) for 12 weeks. To qualify, participants must be between the ages of 18-25 and use tobacco products (smoke cigarettes and/or vape nicotine) and use cannabis (in any form). Participants do not need to be interested in quitting cannabis/marijuana to qualify. This study is being conducted by the Medical University of South Carolina. All procedures are conducted remotely and there is no in-person visits are needed.

Institution
MUSC
Recruitment Contact
Emma Mandel
843-792-4097 or 843-830-0165
smokingstudy@musc.edu

Neurobehavioral and Immune Effects of Citicoline in Youth Alcohol Use Disorder

Date Added
June 6th, 2023
PRO Number
Pro00128800
Researcher
Lindsay Squeglia

List of Studies


Keywords
Adolescents, Alcohol, Brain, Drug Studies, Pediatrics, Psychiatry, Substance Use
Summary

This study is testing citicoline as a possible medication to treat alcohol use disorder. Youth (ages 16-22) will be randomly assigned to receive either citicoline (2000mg per day) and or a placebo for four weeks.

All participants will receive brief counseling from a trained clinician and will undergo a brain scan and cognitive testing at the beginning and end of the treatment.

Participants must provide informed consent and youth under 18 must have parental consent to participate. The full study will last approximately one month.

Compensation is available to those who qualify.

Institution
MUSC
Recruitment Contact
Cori Herring
843-792-8207
herrinco@musc.edu

MUSC Specialized Center of Research Excellence (SCORE) on Sex Differences: Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults

Date Added
May 31st, 2023
PRO Number
Pro00128725
Researcher
Andreana Benitez

List of Studies


Keywords
Substance Use
Summary

The purpose of this study is to learn more about how cannabis use affects memory, thinking, and stress response in older adults, and how ovarian hormones affect them in older women. Participants will undergo a screening process over telehealth to confirm eligibility. There is a second telehealth visit to complete questionnaires, a cognitive testing battery, and a medical history. There is one visit in the clinic where participants will provide urine and saliva samples for drug and alcohol testing and a blood sample for a lipid testing, and complete additional cognitive tasks. They will then complete CREMA sessions (Cue Reactivity Ecologic Momentary Assessment) at home, two times a day for ten days. CREMA sessions include answering questions about marijuana use and sleep, and rating stress and craving.

Institution
MUSC
Recruitment Contact
Lisa Nunn
843-792-0476
jenkinli@musc.edu

MUSC Specialized Center of Research Excellence (SCORE) on Sex Differences: Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults

Date Added
May 31st, 2023
PRO Number
Pro00128725
Researcher
Andreana Benitez

List of Studies


Keywords
Substance Use
Summary

The purpose of this study is to learn more about how cannabis use affects memory, thinking, and stress response in older adults, and how ovarian hormones affect them in older women. Participants will undergo a screening process over telehealth to confirm eligibility. There is a second telehealth visit to complete questionnaires, a cognitive testing battery, and a medical history. There is one visit in the clinic where participants will provide urine and saliva samples for drug and alcohol testing and a blood sample for a lipid testing, and complete additional cognitive tasks. They will then complete CREMA sessions (Cue Reactivity Ecologic Momentary Assessment) at home, two times a day for ten days. CREMA sessions include answering questions about marijuana use and sleep, and rating stress and craving.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Lisa Nunn
843-792-0476
jenkinli@musc.edu

MUSC Specialized Center of Research Excellence (SCORE) on Sex Differences: Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults

Date Added
May 31st, 2023
PRO Number
Pro00128725
Researcher
Andreana Benitez

List of Studies


Keywords
Substance Use
Summary

The purpose of this study is to learn more about how cannabis use affects memory, thinking, and stress response in older adults, and how ovarian hormones affect them in older women. Participants will undergo a screening process over telehealth to confirm eligibility. There is a second telehealth visit to complete questionnaires, a cognitive testing battery, and a medical history. There is one visit in the clinic where participants will provide urine and saliva samples for drug and alcohol testing and a blood sample for a lipid testing, and complete additional cognitive tasks. They will then complete CREMA sessions (Cue Reactivity Ecologic Momentary Assessment) at home, two times a day for ten days. CREMA sessions include answering questions about marijuana use and sleep, and rating stress and craving.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Lisa Nunn
843-792-0476
jenkinli@musc.edu

Sex Differences in the Interface between Cannabis Use and Stress among Emerging Adults

Date Added
May 2nd, 2023
PRO Number
Pro00127995
Researcher
Kevin Gray

List of Studies


Keywords
Adolescents, Drug Studies, Psychiatry, Substance Use
Summary

This study is enrolling emerging adults (ages 18-25) with cannabis use disorder (CUD) to examine sex differences in (a) cannabis withdrawal symptoms during short-term cannabis abstinence, (b) cannabidiol (CBD) versus placebo effects on stress reactivity during short-term cannabis abstinence, and (c) the relationship between stress reactivity and time to cannabis relapse after short-term cannabis abstinence. The proposed study is designed to reveal sex differences and guide the development of tailored treatments that address factors disproportionately affecting emerging adult females with CUD.

Participants will complete an assessment visit to determine eligibility. Eligible participants will be scheduled for their next visit and will be instructed to abstain from cannabis use for 3 days. Participants will be set up with a phone application (app) and given instructions on its use. This app will send twice daily, random surveys everyday throughout study participation with questions about cannabis use, cravings, and overall mood. Participants will also complete twice daily saliva samples.

At the end of the 3 days, participants will return to the clinic for their second visit. Participants will complete a urine and blood sample at each visit. After eating a snack, participants will receive one dose of CBD (800mg) or placebo and then participate in a stress task. Upon completion of the stress task, participants will complete 3 saliva samples and then be discharged after evaluation by research staff. After the completion of Visit 2, participants will continue to complete twice daily surveys for 10 days. The study will last approximately 14 days.

There are risks involved with participating in this study, including risks associated with CBD, risks associated with the stress task and study procedures, emotional distress from answering personal questions, and loss of confidentiality. There is a risk of experiencing cannabis withdrawal symptoms during the 3-day period of cannabis abstinence. Some potential risks related to CBD include dry mouth, diarrhea, reduced appetite, drowsiness, and fatigue. There is a risk of loss of confidentiality, but the researchers will code the samples and research information to protect privacy. There are no direct benefits to the participant, but we hope the knowledge gained will help us inform future clinical strategies to address cannabis use in emerging adults.

Institution
MUSC
Recruitment Contact
Sarah Bourne
843-792-5239
bourne@musc.edu

Targeting the Shared Substrates of Alcohol Misuse and Cognitive Impairment: Accelerated rTMS for Older Adults with Alcohol Use Disorder

Date Added
May 2nd, 2023
PRO Number
Pro00127570
Researcher
Lisa McTeague

List of Studies


Keywords
Alcohol, Brain, Psychiatry, Substance Use
Summary

Alcohol misuse is a risk factor for early onset cognitive impairment, contributing to 10% of early onset dementia, with risk corresponding to consumption. Additionally, continued drinking risks worsening cognitive decline and dementia progression, while worsening cognitive impairment contributes to drinking escalation. Repetitive transcranial magnetic stimulation (rTMS) has been shown to improve cognition in Alzheimer's Disease and Related Dimentias (ADRD) and separately reduce heavy drinking in alcohol use disorder. Our objective is to optimize rTMS for simultaneous mitigation of both drinking and cognitive dysfunction in older adults.

Institution
MUSC
Recruitment Contact
Charleston Alcohol Research Center
843-792-1222
alcoholstudy@musc.edu

Impact of stress and craving on return to cannabis use in postpartum women

Date Added
May 2nd, 2023
PRO Number
Pro00128029
Researcher
Constance Guille

List of Studies


Keywords
Drug Studies, Hormones, Non-interventional, Pregnancy, Substance Use, Women's Health
Summary

Cannabis is the most commonly used illicit substance among pregnant and postpartum women, with the postpartum period being a common time for relapse to cannabis. Currently there are no interventions for preventing return to cannabis use during this vulnerable time. The goal of this research is to better understand risk factors such as stress, craving, anxiety, mood, sleep, and hormone levels that may contribute to return to cannabis use during the postpartum period in order to help develop targeted prevention and treatment interventions in the future.

Institution
MUSC
Recruitment Contact
Lisa Nunn
843-792-0476
jenkinli@musc.edu



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