This study is open to people between 18 and 65 years of age with opioid use disorder. Opioid use disorder is also called opioid addiction or opioid dependence. People can join the study if they currently take a medicine called buprenorphine. People with opioid dependence can act on impulse, which can lead to risky behaviours. The purpose of this study is to find out whether a medicine called BI 1356225 improves impulse control in people with opioid dependence. Participants are put into 2 groups by chance. One group takes BI 1356225 tablets and the other group takes placebo tablets. Placebo tablets look like BI 1356225 tablets but do not contain any medicine. Participants take a tablet once a day for 8 days. All participants also continue taking buprenorphine. Participants are in the study for up to 6 weeks. During this time, they visit the study site 3 times. At visit 2, participants stay at the study site for 9 nights. Doctors test participants' impulsivity using tasks or games on a computer and questionnaires. The results are compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
12
BI 1356225
Placebo
Collaborative Neuroscience Research, LLC, Los Alamitos
Los Alamitos, California, United States
University of California Los Angeles
Los Angeles, California, United States
iResearch Atlanta
Decatur, Georgia, United States
Hassman Research Institute-Marlton-66897
Marlton, New Jersey, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Change from baseline in k parameter of the delay discounting task (DDT) on Day 8
In the DDT, participants make choices on the screen between a smaller, immediate amount of money and a larger, delayed amount. Steep discounting of delayed rewards is indicative of cognitive impulsivity. The key outcome variable for this task is the discount rate (k) or rate at which delayed rewards lose their value.
Time frame: at baseline and at Day 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.