TMS to Improve Recovery Outcomes Among Patients With Opioid Use Disorder (OUD) and Alcohol Use Disorder (AUD)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18+ years old

Enrolled in the Intensive Outpatient Program at Another Chance Drug & Alcohol Rehab Center of Portland, Portland, OR.

Diagnosed with Opioid Use Disorder

Diagnosed with Alcohol Use Disorder

Disqualifiers

Children <18 years old

Pregnant

Non-English speaking

Currently taking prescription benzodiazepines or anti-convulsive medications

Trial design

Design model

Parallel

Treatments tested in this trial

  • TMS Low-Dose

    Device

    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).

  • TMS High-Dose

    Device

    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).

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Treatment As UsualNo intervention 0 interventions
Group B: 3-Minute TMSActive comparator 1 intervention
Group C: 9-Minute TMSActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Engagement in Treatment As Usual activities

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
2

Engagement in Treatment As Usual Activities

Number of individual treatment sessions attended from baseline assessment to follow up.

Time frame
4 weeks
3

Engagement in Treatment As Usual Activities

Number of group treatment sessions attended from baseline assessment to follow up.

Time frame
4 weeks
4

Engagement in Treatment As Usual Activities

Number of negative urine toxicology screens for illicit drugs or unprescribed medications from baseline assessment to follow up.

Time frame
4 weeks

Secondary outcomes

1

Delay Discounting

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
2

Go/No-Go Task

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
3

Balloon Analogue Risk Task

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
4

Barratt Impulsiveness Scale-11

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

Other outcomes

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