Another Chance Drug & Alcohol Rehab Center of Portland
Portland, Oregon, 97232, United States
Location status: Recruiting
Location contact
Benjamin Schwartz, MD
CONTACT
Benjamin Schwartz, MD
SUB_INVESTIGATOR
John Morgan, CADC II, QMHA
CONTACT
NCT Number: NCT07171359
The study aims to explore the potential of Transcranial Magnetic Stimulation (TMS), particularly Theta Burst Stimulation (TBS), as an adjunctive treatment to enhance recovery outcomes (consumption and craving; withdrawal symptoms; mental, physical, sleep, and cognitive health; engagement with therapy, etc.) in individuals with Opioid Use Disorder (OUD) and individuals with Alcohol Use Disorder (AUD). This project will be completed in partnership with Another Chance Rehab (Portland): Portland's top addiction treatment program offering evidence-based treatment programs for a range of substance use disorders. Another Chance Rehab will serve as the project site for this work.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Portland, Oregon, 97232, United States
Location status: Recruiting
Benjamin Schwartz, MD
CONTACT
Benjamin Schwartz, MD
SUB_INVESTIGATOR
John Morgan, CADC II, QMHA
CONTACT
The investigators will conduct a prospective, randomized, controlled trial. To identify which TMS protocol is most efficacious, there will be three arms to this study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
one 3-minute session of TMS TBS delivered each morning, prior to commencement of their regularly scheduled daily therapy activities, for 5 days/week, for a total of four-weeks (20 sessions total).
One 9-minute session of TMS TBS delivered each morning, prior to commencement of their regularly scheduled daily therapy activities, for 5 days/week, for a total of four-weeks (20 sessions total).
Time frame: 4 weeks
The Investigators will compare engagement in treatment as usual within and between groups by Number of Days in attendance from baseline assessment to follow up.
Time frame: 4 weeks
Number of individual treatment sessions attended from baseline assessment to follow up.
Time frame: 4 weeks
Number of group treatment sessions attended from baseline assessment to follow up.
Time frame: 4 weeks
Number of negative urine toxicology screens for illicit drugs or unprescribed medications from baseline assessment to follow up.
Time frame: 4 weeks
On this computer task, participants complete 5 trials where they are asked to choose between an immediate or a delayed reward (e.g., $5 now or $10 in 3 weeks). In this version of the delay discounting task, the delay duration adjusts depending on participants' choice on the previous trial. If participants choose the immediate reward, the next trial will have a shorter duration for the delayed reward (e.g., $10 in 1 day); if participants choose the delayed reward, the next trial will have a longer duration for the delayed reward (e.g., $10 in 2 years). Performance on the delay discounting task is measured by calculating the discounting rate, or the rate at which the value of a reward decreases as a function of delay. Higher discounting rates indicate a preference for smaller immediate rewards over larger delayed rewards and is associated with higher impulsivity. (Koffarnus & Bickel, 2014)
Time frame: 4 weeks
On this computer task, participants are asked to respond to stimuli by either executing ("go" stimuli) or withholding a response ("no-go" stimuli). More "go" stimuli are presented than "no-go" stimuli to induce a prepotent response. Performance on the Go/No-Go task is measured by calculating the proportion of commission errors (i.e., false alarms, making a response to a "no-go" stimulus), omission errors (i.e., misses, failing to respond to a "go" stimulus), and the response times to "go" stimuli. Higher proportions of commission errors are indicative of an inability to inhibit a response, sometimes referred to as rapid-response impulsivity. (Donders, 1969)
Time frame: 4 weeks
On this computer task, participants are shown a balloon and told that each press of a button will increase the size of the balloon and reward them with a small, hypothetical monetary reward. However, after a variable number of pumps, the balloon will explode, causing them to lose all accumulated rewards on that trial. Participants can pump up the balloon as much as they want before moving onto the next trial. Performance on the BART is measured by calculating the average number of pumps on each balloon excluding balloons that exploded. A higher average number of pumps is associated with more impulsiveness. (BART; Lejuez et al., 2002)
Time frame: 4 weeks
On this 30-item questionnaire, participants use a 4-point Likert-type scale (1 = Rarely/Never, 4 = Almost Always/Always) to indicate how frequently statements like "I do things without thinking" and "I concentrate easily" apply to themselves. The BIS-11 total score is a summed score of all responses and can range from 30 to 120, with higher scores indicating higher levels of impulsiveness. There is also an option to calculate scores for three aspects of impulsiveness: attentional, motor, and nonplanning. These subscale scores are calculated by summing the number of associated items. The attentional impulsiveness subscale consists of 8 items, and total scores can range from 8 to 32; the other two subscale scores are 11 items each and scores can range from 11 to 44. (BIS-11; Patton et al., 1995)
Time frame: 4 weeks
On this 40-item questionnaire, participants are shown two choices, like "A. I prefer friends who are excitingly unpredictable or B. I prefer friends who are reliable and predictable," and asked to select the statement that most or best describes how they feel. One point is given for the more sensation-seeking choice. The SSS total score is the sum of all more sensation-seeking choices and can range from 0 to 40, with higher scores indicating more sensation-seeking. There is also an option to calculate scores for each of the four factors that make up sensation-seeking: [social and sexual] disinhibition, boredom susceptibility, thrill and adventure seeking, and experience seeking. Each of these scales is made up of 10 of the items and scores can range from 0 to 10. (SSS; Zuckerman et al., 1964)
Contact information is provided by the study sponsor or research team.
Matthew E Layton, MD, PhD
CONTACT
Poppy M Gardiner, PhD
CONTACT
Washington State University
Other
Transcranial Magnetic Stimulation (TMS) to Improve Recovery Outcomes Among Patients With Opioid Use Disorder (OUD) and Alcohol Use Disorder (AUD)
Acronym: TMS4OUDAUD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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