Table 2.

Sample Guidance Sent to Potential Sites for Self Evaluation

The main challenge is to identify settings where we are most likely to retain participants in the study over the course of 12 weeks, and ideally the next 6 months as well. The following features in a CTP may make it a good candidate to be successful in this study:

Residential treatment of 21 to 30 days in length.

Admission of 10–12 patients with stimulant abuse/dependence a month to residential treatment

Ideally, patients continue in some form of substance abuse treatment, such as residential treatment followed by some form of outpatient treatment for as close to 3 months as possible. The best scenario is where they continue in some form of treatment for the full 9 months of the study, to maximize the chances of continuing in the study; however this is not essential.

Relatively low dropout rate during the first 3 months of treatment to maximize the probability of retention in the study. A good rate of successful transition to outpatient treatment (relatively low loss of patients to follow-up in the transition).

After discharge, maintenance of participants in outpatient treatment at a program at the residential treatment setting OR somewhere close enough to the residential treatment setting (where we will have the exercise equipment, health education classes and research staff) to maximize the chances that participants will come back to the study location to exercise or receive health education at protocol required study visits. This means either the participants continue in outpatient treatment in the same organization in the same or nearby physical location, OR go to another treatment program but are likely to come back to the study site for exercise or health education during this time, OR are just likely to come back for the study visits.

The site must be willing to retain patients in treatment if they relapse so we do not lose them from the study (other than for special circumstances).

The site must be willing to let participants exercise or be seen for health education at their residential (or other chosen) study location (the only place where we plan to have equipment and health education) for the full 9 months of the study, whether the participant drops out of treatment or uses substances, so we do not lose them to the study (some situations may require such discontinuation for safety reasons, etc.).

Since many treatment plans do not continue for 9 months or even 3 months, the participants should live close enough to the residential treatment program with the exercise equipment that they may be reasonably be expected to come back to exercise or for health education for up to 9 months.

No formal or current exercise program, unless the duration of exercise in the program is one hour or less per week.