Ignite Creation Date:
2024-05-06 @ 2:55 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04464421
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2020-06-23
Brief Title:
SMART Effectiveness Trial
Sponsor:
Karen Derefinko PhD
Organization:
University of Tennessee
Study Overview
Official Title:
Pilot Test of Contingency Management and Brief Motivational Interviewing Substance Free Activity Session Interventions Mindfulness-Based Adherence Promotion
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The current study piloted two psychosocial interventions developed to increase buprenorphine-naloxone adherence in individuals with opioid use disorder OUD Participants were randomized to receive either contingency management CM or a brief substance free activities session plus mindfulness BSM cognitive-behavioral intervention Participants were 48 newly presenting patients from an OUD treatment clinic The primary outcome was medication adherence as measured by buprenorphine metabolite in urine and presence at 2 or more of 4 possible physician visits
Detailed Description:
We engaged with referred OUD patients at the time of their initial visit to the clinic Interested patients were informed about the study in a private room and if eligible were consented and randomized to condition Randomization occurred in blocks of 4 At the next physician visit participants engaged in their first intervention activities either CM or BSM This was repeated for the following 3 physician visits
CM Contingency Management CM The CM intervention provided participants with a gift card at each of the first 4 follow up physician visits to the clinic where the participants urine showed evidence of buprenorphine use The strategy for CM rewards was based upon Petrys fishbowl draw where variable values of gift cards were available for draw at each positive buprenorphine urine toxicology result For the current study which was conducted when COVID safety requirements were still high a computerized picker wheel was used rather than an actual fishbowl to reduce possible viral transmission Participants watched the wheel spin and told the interventionist when to stop the spin at which time the value of the gift card was displayed The picker wheel was programmed to include a 60 chance of a 25 gift card a 20 chance of a 50 gift card and a 20 chance of a 100 gift card The average expected value of gift cards at this rate was 45 or 180 total across 16 weeks well below the typical range used in similar work
BSM Brief Motivational Interviewing plus Substance Free Activities Session plus Mindfulness BSM The BSM intervention included the following topics 1 Short and Long-Term Goals Identifying goals eg What are your goals for this monthfor the next 5 years requirements needed to achieve these goals eg What would you need to do to achieve those goals and the potential role of relapse in jeopardizing these goals 2 Personalized Feedback on Recent Time Allocation eg time spent with family work educationhobbiescreative activities exercisetime in natureself-care watching tvsurfing the internet religious or spiritual activities recovery and nonrecovery activities along with open ended questions asking about the extent to which their recent time allocation is consistent with their goals and values 3 Episodic Future Thinking An experiential intervention that prompts individuals to describe personal emotional and situational details of a valued future outcome that they desire 4 Substance Free Activities Based upon named hobbies and interests participants were offered a personalized list of locally available substance-free activities developed by the interventionist 5 Stop Observe Breathe Expand Respond SOBER Breathing Space This exercise is intended to bring awareness to ones experiences without judgment This technique includes the following steps Stop or Slow down Observe what is happening Bring attention to Breathing Expand awareness to the whole body Respond mindfully with awareness
CM Contingency Management CM The CM intervention provided participants with a gift card at each of the first 4 follow up physician visits to the clinic where the participants urine showed evidence of buprenorphine use The strategy for CM rewards was based upon Petrys fishbowl draw where variable values of gift cards were available for draw at each positive buprenorphine urine toxicology result For the current study which was conducted when COVID safety requirements were still high a computerized picker wheel was used rather than an actual fishbowl to reduce possible viral transmission Participants watched the wheel spin and told the interventionist when to stop the spin at which time the value of the gift card was displayed The picker wheel was programmed to include a 60 chance of a 25 gift card a 20 chance of a 50 gift card and a 20 chance of a 100 gift card The average expected value of gift cards at this rate was 45 or 180 total across 16 weeks well below the typical range used in similar work
BSM Brief Motivational Interviewing plus Substance Free Activities Session plus Mindfulness BSM The BSM intervention included the following topics 1 Short and Long-Term Goals Identifying goals eg What are your goals for this monthfor the next 5 years requirements needed to achieve these goals eg What would you need to do to achieve those goals and the potential role of relapse in jeopardizing these goals 2 Personalized Feedback on Recent Time Allocation eg time spent with family work educationhobbiescreative activities exercisetime in natureself-care watching tvsurfing the internet religious or spiritual activities recovery and nonrecovery activities along with open ended questions asking about the extent to which their recent time allocation is consistent with their goals and values 3 Episodic Future Thinking An experiential intervention that prompts individuals to describe personal emotional and situational details of a valued future outcome that they desire 4 Substance Free Activities Based upon named hobbies and interests participants were offered a personalized list of locally available substance-free activities developed by the interventionist 5 Stop Observe Breathe Expand Respond SOBER Breathing Space This exercise is intended to bring awareness to ones experiences without judgment This technique includes the following steps Stop or Slow down Observe what is happening Bring attention to Breathing Expand awareness to the whole body Respond mindfully with awareness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None