Recommendation 2 Recognizing that immunotherapy and sustained-release medications will be used in off-label situations that have not been specifically approved by the Food and Drug Administration, the National Institute on Drug Abuse should support preclinical studies addressing the potential safety and efficacy of these medications when given to vulnerable populations (e.g., pregnant women and their fetuses, adolescents, etc.). Long-term studies should be done with laboratory animals of different ages, as well as their offspring, before trials with vulnerable human populations are undertaken.
Recommendation 3 The National Institute on Drug Abuse should support studies of the likely extent and nature of off-label drug use, including factors and incentives that would promote or retard such use, and the opportunities for policy makers to intervene should the patterns of off-label use depart from what is in the best interest of the society.
Immunotherapy medications present unique and far-reaching challenges for our current system of medical and addiction treatment. The development of these therapies highlights the need to view addiction as a chronic medical condition requiring long-term management. As such, they will require the historically separate systems of medical care and addiction treatment to forge new partnerships to ensure that both medication and integrated psychosocial services are available to those in need. Offering these treatments in primary care settings should reduce the stigma of substance abuse treatment, but the potential for long-term markers of these treatments or false-positive markers of drug use may discourage treatment participation.
Recommendation 4 The National Institute on Drug Abuse should support studies of whether the potential for discrimination due to long-lasting markers in the blood or urine deters people with drug dependence from accepting immunotherapies. The effects of immunotherapies on false-positive and false-negative drug testing results should also be studied.
Recommendation 5 The National Institute on Drug Abuse should support clinical effectiveness studies and financing models that integrate the new pharmacotherapies with psychosocial services in specialty addiction and primary medical care settings.