Prescription Drug Abuse (Not Dependent) Clinical Trial
— MAPDEOfficial title:
Mobile Application for Prescription Drug-Abuse Education (MAPDE)
Verified date | June 2019 |
Source | Naval Health Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aims of this pilot study are: (1) to assess the feasibility and acceptability of a mobile application to educate military members about the risks of prescription drug misuse; (2) to determine if there is evidence that the mobile application plus treatment as usual reduces the risk of prescription drug misuse and shows differences in related measures compared to treatment as usual among military medical clinic patients currently taking prescription medication; and (3) if evidence of reduced risk is found, to estimate effect sizes for a future effectiveness trial. The pilot study will use a randomized controlled design with two groups. The control group will be provided with treatment as usual (TAU), and the experimental group will be provided with the prescription drug-abuse educational smartphone application in addition to treatment as usual (app + TAU). Self-reported measures of risk of misuse and related attitudes and knowledge will be administered to all participants at baseline, 1 month, and 3 months. The mobile app is a brief intervention designed to help military members to assess their risk for medication misuse and provide individualized feedback on risk level with recommendations for reducing risk. The app also contains other features, including sections in which to store information on current medications and look up drug interactions and provides resources for help.
Status | Completed |
Enrollment | 80 |
Est. completion date | October 17, 2018 |
Est. primary completion date | June 11, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Age 18 or older (up to 55 years old) - On active-duty status - In the Navy or Marine Corps - Currently prescribed a medication with the potential for misuse - Owns a smartphone Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
United States | Naval Health Research Center | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Naval Health Research Center | Intelligent Automation, Inc. |
United States,
Adams LL, Gatchel RJ, Robinson RC, Polatin P, Gajraj N, Deschner M, Noe C. Development of a self-report screening instrument for assessing potential opioid medication misuse in chronic pain patients. J Pain Symptom Manage. 2004 May;27(5):440-59. — View Citation
Bodenlos, J. S., Malordy, A., Noonan, M., Mayrsohn, A., & Mistler, B. (2014). Prescription Drug Attitudes Questionnaire: Development and Validation. Psychology, 5(14), 1687-1693.
Butler SF, Budman SH, Fernandez KC, Houle B, Benoit C, Katz N, Jamison RN. Development and validation of the Current Opioid Misuse Measure. Pain. 2007 Jul;130(1-2):144-56. Epub 2007 May 9. Erratum in: Pain. 2009 Mar;142(1-2):169. — View Citation
Kroenke K, Spitzer RL, Williams JB, Löwe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009 Nov-Dec;50(6):613-21. doi: 10.1176/appi.psy.50.6.613. — View Citation
Morasco BJ, Dobscha SK. Prescription medication misuse and substance use disorder in VA primary care patients with chronic pain. Gen Hosp Psychiatry. 2008 Mar-Apr;30(2):93-9. doi: 10.1016/j.genhosppsych.2007.12.004. — View Citation
O'Neill AK. Norms, Attitudes, Perceptions, and Intentions for Benzodiazepine Prescription Drug Abuse among Adolescents (2011). Master's Theses and Doctoral Dissertations. Paper 422.
Prins A, Ouimette P, Kimerling R, Cameron RP, Hugelshofer DS, Shaw-Hegwer J, …Sheikh JI. (2003). The primary care PTSD screen (PC-PTSD): development and operating characteristics. Primary Care Psychiatry, 9(1), 9-14.
Schwab K, Baker G, Ivins B, Sluss-Tiller M, Lux W, Warden D. (2006). The Brief Traumatic Brain Injury Screen (BTBIS): Investigating the validity of a self report instrument for detecting traumatic brain injury (TBI) in troops returning from deployment in Afghanistan and Iraq. Neurology, 66, A235.
Weathers FW, Litz BT, Herman DS, Huska JA, Keane TM. (1993, October). The PTSD Checklist (PCL): Reliability, validity, and diagnostic utility. Paper presented at the annual meeting of the International Society of Traumatic Stress Studies, San Antonio, TX. Retrieved from http://www.pdhealth.mil/library/downloads/pcl_sychometrics.doc.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Current Opioid Misuse Measure (COMM) | Mean COMM scale score as an indicator of risk for opioid prescription drug misuse. It measures 17 misuse behaviors over the past 30 days for those currently taking medications. Scores can range from 0-4 with higher scores indicating a worse outcome. | Baseline and 1 month | |
Secondary | Pain Medication Questionnaire (PMQ) Shortened Scale | Mean PMQ scale score as an indicator of prescription drug misuse. This 5-item scale was adapted from a brief scale previously used by Morasco and Dobscha (2008), which is actually a subset of the Pain Medication Questionnaire (PMQ) scale (Adams et al., 2004). The original scale was created to screen for prescription drug misuse among chronic pain patients undergoing opioid therapy, and the shortened scale was created for use among a military veteran population. Scale ranges from 1-5 with higher scores indicating a worse outcome. | Baseline and 1 month | |
Secondary | Prescription Drug Misuse-related Attitudes | A scale score for items from the 8-item Prescription Drug Attitudes Questionnaire (PDAQ; Bodenlos et al., 2014), which were adapted by the investigators for the military. The scores range from 1-5 with higher scores indicating a worse outcome. | Baseline and 1 month | |
Secondary | Prescription Drug Misuse-related Knowledge | Mean number of correct knowledge items. Twenty-three multiple choice knowledge items assessed the participant's level of knowledge of the definition of misuse and related educational points. Possible range is 0-23 with higher scores reflecting higher knowledge levels. | Baseline and 1 month | |
Secondary | Preparedness to Talk About Misuse | Two investigator-developed items were used to assess the level of preparedness to talk to others (i.e., chain of command, doctor) about concerns related to one's own possible prescription drug misuse. The scale ranged from 1-5 with higher scores indicating a better outcome. | Baseline and 1 month |
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