Bone CW, Goodfellow AM, Vahidi M, Gelberg L Prevalence of Sexual Violence and its Association with Depression among Male and Female Patients with Risky Drug Use in Urban Federally Qualified Health Centers. J Urban Health. 2018 Feb;95(1):111-115. doi: 10.1007/s11524-017-0213-7.
Padwa H, Ni YM, Barth-Rogers Y, Arangua L, Andersen R, Gelberg L Barriers to drug use behavior change among primary care patients in urban United States community health centers. Subst Use Misuse. 2014 May;49(6):743-51. doi: 10.3109/10826084.2013.866962. Epub 2013 Dec 20.
Reddy AT, Andersen RM, Gelberg L Clinicians' Beliefs and Practices Regarding Drug Use Care of Their Community Health Center Patients. J Addict Med. 2015 Nov-Dec;9(6):447-53. doi: 10.1097/ADM.0000000000000158.
Swendeman D, Sumstine S, Aguilar E, Gorbach PM, Comulada WS, Gelberg L Feasibility and Acceptability of Mobile Phone Self-monitoring and Automated Feedback to Enhance Telephone Coaching for People With Risky Substance Use: The QUIT-Mobile Pilot Study. J Addict Med. 2021 Apr 1;15(2):120-129. doi: 10.1097/ADM.0000000000000707.
mHealth to Enhance & Sustain Drug Use Reduction of the QUIT BI in Primary Care
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.