Table 1.

Clinical trials with a behavioral component or intervention in the Clinical Trials Network

Protocol	Intervention	Assessment	AEs	SAEs
Motivational Enhancement Treatment to Improve Treatment Engagement and Outcome in Individuals Seeking Treatment for Substance Abuse	Motivational Enhancement Therapy	Participant self report	None specified	Hospitalization for any reason; death
Motivational Interviewing	Motivational Interviewing	Participant self report	None specified	Hospitalization for any reason; death
Motivational Incentives for Enhanced Drug Abuse Recovery: Drug Free Clinics	Motivational Incentive Program	Structured questions	Increased gambling; hospitalization; drug overdose requiring medial intervention	Hospitalization; increased gambling; death
Motivational Incentives: Methadone Clinic	Incentive group	Structured questions	Increased gambling; hospitalization; drug overdose requiring medial intervention	Hospitalization; increased gambling; death
Smoking Cessation Treatment with Transdermal Nicotine Replacement Therapy in Substance Abuse Rehabilitation Programs	Smoking Cessation Counseling with Nicotine Patches	Open ended question	Any reaction, side effect, or untoward event; side effect of the patch; symptom of nicotine overdose; new illness, symptom, sign or worsening of a pre-existing condition or abnormality	Death; life-threatening event; disabling event; hospitalization; congenital anomaly; event that requires intervention to prevent permanent impairment/damage
A Feasibility Study of a Telephone Enhancement Procedure to Improve Participation in Continuing Care Activities	Telephone Enhancement Procedure	Open ended question	New illness, symptom, sign, or worsening of pre-existing condition or abnormality	Death; life-threatening event; disabling event; hospitalization; birth defect
Motivational Enhancement Therapy to Improve Treatment Utilization and Outcome in Pregnant Substance Users	Motivational Enhancement Therapy	Open ended question	Vaginal bleeding; abdominal pain; leaking fluid or uterine contractions before week 37 of pregnancy; vision changes; headaches; swelling of face or hands; decreased fetal movement; suicidal or homicidal ideation	Death; life-threatening event; disabling event; hospitalization; birth defect; intervention to prevent any of above listed serious events
Brief Strategic Family Therapy For Adolescent Drug Abusers	Brief Strategic Family Therapy	Structured questions	Arrest; runaway; kicked out of home; school suspension/expulsion/dropout; violence	Physical/sexual abuse; suicidal behavior; homicidal behavior; hospitalization; death; other
Women’s Treatment for Trauma and Substance Use Disorders	Seeking Safety	Open ended question	Worsening of PTDS, SUD or depressive symptoms	Life threatening (drug over-dose, suicidal ideation/attempt, inpatient hospitalization)
HIV and HCV Risk Reduction Interventions in Drug Detoxification and Treatment Settings	Pretest and post test counseling; Therapeutic alliance	Open ended question	Reaction, side effect, or untoward event that occurs during the course of the clinical trial	Death; life-threatening event; disabling event; hospitalization (drug overdose, suicidality); birth defect; intervention to prevent any of above listed serious events emotional distress due to HIV or HCV infection
Reducing HIV/STD Risk Behaviors: A Research Study for Men in Drug Abuse Treatment	HIV/AIDS group therapy	Open ended question	Reaction, side effect or untoward event that occurs during course of trial	Death; life-threatening event; disabling event; hospitalization; birth defect; intervention to prevent any of above listed serious events
Reducing HIV/STD Risk Behaviors: A Research Study for Women in Drug Abuse Treatment	HIV/AIDS group therapy	Open ended question	Abusive partner behavior; marked increase in emotional distress	Death; life-threatening event; disabling event; hospitalization; birth defect; intervention to prevent any of above listed serious events
Job Seekers Training for Patients with Drug Dependence	Basic job training program	Open ended question	Psychological distress due to assessment or training procedures, or physical injuries related to the job search process or to the employment situation	Death; life-threatening event; disabling event; hospitalization (drug overdose, suicidality); birth defect; intervention to prevent any of above listed serious events
Motivational Enhancement Treatment to Improve Treatment Engagement and Outcome for Spanish Speaking Individuals Seeking Treatments for Substance Abuse	Motivational Enhancement Therapy	Open ended question	Hospitalizations for normal child birth, planned surgical procedures, pre-existing or non threatening medical conditions	Death; life-threatening event; disabling event; requires or prolongs hospitalization and a congenital anomaly/birth defect
Stimulant Abuser Groups to Engage in 12 Step	Combined group and individual 12 step facilitation	Not specified	New illness, symptom, sign, or disease or a worsening of a preexisting condition; admission to a hospital/residential facility for drug detox; hospitalization for preplanned surgery, labor, and delivery	Death; life-threatening event; disabling event; hospitalization; birth defect; intervention to prevent any of above listed serious events.