Guidance for treating a participant in the AD-SMART trial in an acute clinical setting.
Assume the participant is taking the active medicine
In most acute clinical settings, it should be assumed that the trial participant has received the active investigational medicinal product (IMP), either atomoxetine or metformin. Clinicians should proceed with appropriate clinical management without unblinding, if possible.
Unblinding treatment allocation should only be performed in a medical emergency where knowledge of the specific treatment will directly alter the participant's immediate clinical management.
If unblinding is necessary
- Contact the local site. Discuss the circumstances with the participant's local trial site before unblinding, provided this will not delay urgent treatment. Site contact details, including out-of-hours numbers, are on the participant's trial card.
- Contact the central trial team. If the local site cannot be reached, use the trial emergency numbers (on the participant card) to reach delegated members of the AD-SMART trial team, who will escalate as required.
- Use rapid unblinding. If no member of the trial team can be contacted promptly, go directly to the rapid unblinding procedure so that critical treatment is not delayed.
Medicines in the trial
- Atomoxetine
- Metformin
- Placebo