Neurosteroids as Novel Therapeutic Agents for Chronic Pain in OEF/OIF Veterans
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|ClinicalTrials.gov Identifier: NCT01898013|
Recruitment Status : Recruiting
First Posted : July 12, 2013
Last Update Posted : April 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lower Back Pain||Drug: Pregnenolone Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Neurosteroids as Novel Therapeutic Agents for Chronic Pain in OEF/OIF Veterans|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2018|
Active Comparator: Pregnenolone
Pregnenolone fixed escalating up to 500mg/day will consist of the following schedule:
Visit 1 (week -1, screening visit) and pain symptom assessment (no study medication) Visit 2 (week 0) placebo lead-in (all participants) Visit 3 (week 1, baseline visit): 50mg PO, BID x 1 week, Visit 4 (week 2): 150mg PO, BID x 1 week, Visit 5 (week 3): 250mg PO, BID for two weeks. Visit 6 (week 5): No medication will be dispensed; study medication will be tapered by 100mg per day and then discontinued.
Placebo Comparator: Placebo
Placebo will be administered exactly the same as the active comparator (pregnenolone) and will consist of the following schedule:
Visit 1 (week -1, screening visit) and pain symptom assessment (no study medication) Visit 2 (week 0) placebo lead-in (all participants) Visit 3 (week 1, baseline visit): placebo PO, BID x 1 week, Visit 4 (week 2): placebo PO, BID x 1 week, Visit 5 (week 3): placebo PO, BID for two weeks. Visit 6 (week 5): No medication will be dispensed; study medication will be tapered in the exact manner as active study medication and then discontinued.
- Pain rating [ Time Frame: an average of 7 weeks ]Primary efficacy outcome measure will be the weekly mean of the 24-hour average pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst pain).
- Brief Pain Inventory [ Time Frame: an average of 7 weeks ]The The Brief Pain Inventory (BPI) is a self-reported scale that measures the severity of pain and the interference of pain on function. The scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, average pain in the past 24 hours, and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
- Beck Depression Inventory [ Time Frame: an average of 7 weeks ]The Beck Depression Inventory is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression (Beck, et al., 1961). Scores range from 0 (no depression) to 63 (severe depression).
- Davidson Trauma Scale [ Time Frame: an average of 7 weeks ]The Davidson Trauma Scale (DTS) is a 17-item self-report measure that assesses the 17 DSM-IV symptoms of PTSD. Items are rated on 5-point frequency (0 = "not at all" to 4 = "every day") and severity scales (0 = "not at all distressing" to 4 = "extremely distressing"). Respondents are asked to identify the trauma that is most disturbing to them and to rate, in the past week, how much trouble they have had with each symptom. The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136).
- Athens Insomnia Scale [ Time Frame: an average of 7 weeks ]The scale assesses the severity of insomnia using diagnostic criteria set forth by the International Classification of Diseases (ICD-10). The eight-item questionnaire evaluates sleep onset, night and early-morning waking, sleep time, sleep quality, frequency and duration of complaints, distress caused by the experience of insomnia, and interference with daily functioning. Scores range from 0 (no sleep disturbance) to 24 (significant sleep disturbance).
- The RAND 36-Item Health Survey [ Time Frame: an average of 7 weeks ]The RAND 36-Item Health Survey laps eight concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. All items are scored so that a high score defines a more favourable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores.
- Connor-Davidson Resilience Scale [ Time Frame: an average of 7 weeks ]The Connor-Davidson Resilience Scale (CD-RISC) has been developed and tested as (i) a measure of degree of resilience, (ii) as a predictor of outcome to treatment with medication or psychotherapy, stress management and resilience-building; (iii) as a marker of progress during treatment; (iv) as a marker of biological (i.e. physical) changes in the brain. The scale also has promise as a method to screen people for high, intermediate or low resilience. The CD-RISC comprises of 25 items, each rated on a 5-point scale (0-4), with higher scores reflecting greater resilience.
- Roland Morris Disability Questionnaire [ Time Frame: an average of 7 weeks ]The measure designed is to assess self-rated physical disability caused by low back pain. This is a 24-item questionnaire. The patient is asked to tick a statement when it applies to him that specific day, this makes it possible to follow changes in time. The end score is the sum of the ticked boxes. The score ranges from 0 (no disability) to 24 (max. disability).
- Patient's Global Impression of Change Scale [ Time Frame: an average of 7 weeks ]A self-report measure that reflects a patient's belief about the efficacy of treatment. There is a 10-point scale depicting patients rating of overall improvement and a 7-point scale to assess change in activity limitations, symptoms, emotions and overall quality of life. Higher scores are indicative of greater improvement for both scales.
- Digit Sequencing Task [ Time Frame: an average of 7 weeks ]
Patients will be presented auditorily with clusters of numbers (e.g., 936) of increasing length. They are asked to tell the experimenter the numbers in order, from lowest to highest.
Measures: number of correct responses
- Tower of London [ Time Frame: an average of 7 weeks ]
Participants will look at two pictures simultaneously. Each picture will show three different colored balls arranged on three pegs, but the balls will be in a unique arrangement in each picture. The patient will give the minimum number of times the balls in one picture would have to be moved in order to make the arrangement of balls identical to that of the other, opposing picture.
Measures: number of correct responses. 20 items administered. 22 items administered if items 1-2 are answered correctly. Scoring is 0-22 (0 being lowest score-greater impairment, 22 being highest score, no impairment).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01898013
|Contact: Jennifer C Naylor, PhD||91928600411 ext firstname.lastname@example.org|
|United States, North Carolina|
|Durham VA Medical Center||Recruiting|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Jennifer C. Naylor, PhD||Durham VA Medical Center|
|Study Director:||Christine E Marx, MD||Durham VA Medical Center|