drugset / Trial / NCT02884908
Pharmacogenetic Treatment With Anti-Glutaminergic Agents for Comorbid PTSD & AUD
Phase 3
Completed
57 enrolled
University of Maryland, Baltimore
National Institute on Alcohol Abuse and Alcoholism (NIAAA) · collab
RandomizedFactorialQuadruple-blindTreatment
Summary
The primary study objective is to determine the efficacy of pregabalin administered orally for a period of 12 weeks in reducing risky drinking and symptoms of posttraumatic stress disorder who have selected genotypes at the gamma-amino butyric acid transporter and receptor genes. The secondary objective is to assess the safety and tolerability of pregabalin in participants with alcohol use disorder and co-occurring posttraumatic stress disorder who have selected genotypes at the gamma-amino butyric acid transporter and receptor genes. The investigators will utilize a sample of African-Americans that includes both genders and individuals with different types of trauma.
Timeline
- Start
- 2017-07-07
- Primary completion
- 2022-01-19
- Completion
- 2022-01-19
Outcome
Missed primary endpoint
registry analysis (superiority test); Pregabalin + BBCET vs Placebo + BBCET; p = 0.80; Mixed Models Analysis NCT02884908 ↗
registry analysis (superiority test); Pregabalin + BBCET vs Placebo + BBCET; p = 0.90; Mixed Models Analysis NCT02884908 ↗
registry analysis (superiority test); Pregabalin + BBCET vs Placebo + BBCET; p = 0.38; Mixed Models Analysis NCT02884908 ↗
Publications
- Background Baldwin DS, Anderson IM, Nutt DJ, Allgulander C, Bandelow B, den Boer JA, Christmas DM, Davies S, Fineberg N, Lidbetter N, Malizia A, McCrone P, Nabarro D, O'Neill C, Scott J, van der Wee N, Wittchen HU. Evidence-based pharmacological treatment of anxiety disorders, post-traumatic stress disorder and obsessive-compulsive disorder: a revision of the 2005 guidelines from the British Association for Psychopharmacology. J Psychopharmacol. 2014 May;28(5):403-39. doi: 10.1177/0269881114525674. Epub 2014 Apr 8.
- Background Baniasadi M, Hosseini G, Fayyazi Bordbar MR, Rezaei Ardani A, Mostafavi Toroghi H. Effect of pregabalin augmentation in treatment of patients with combat-related chronic posttraumatic stress disorder: a randomized controlled trial. J Psychiatr Pract. 2014 Nov;20(6):419-27. doi: 10.1097/01.pra.0000456590.12998.41.
- Background Fowler M, Garza TH, Slater TM, Maani CV, McGhee LL. The relationship between gabapentin and pregabalin and posttraumatic stress disorder in burned servicemembers. J Burn Care Res. 2012 Sep-Oct;33(5):612-8. doi: 10.1097/BCR.0b013e31823dc710.
- Background Guglielmo R, Martinotti G, Clerici M, Janiri L. Pregabalin for alcohol dependence: a critical review of the literature. Adv Ther. 2012 Nov;29(11):947-57. doi: 10.1007/s12325-012-0061-5. Epub 2012 Nov 5.
- Background Johannessen Landmark C. Antiepileptic drugs in non-epilepsy disorders: relations between mechanisms of action and clinical efficacy. CNS Drugs. 2008;22(1):27-47. doi: 10.2165/00023210-200822010-00003.
- Background Martinotti G. Pregabalin in clinical psychiatry and addiction: pros and cons. Expert Opin Investig Drugs. 2012 Sep;21(9):1243-5. doi: 10.1517/13543784.2012.703179. Epub 2012 Jun 24.
- Background Martinotti G, Lupi M, Sarchione F, Santacroce R, Salone A, De Berardis D, Serroni N, Cavuto M, Signorelli M, Aguglia E, Valchera A, Iasevoli F, Di Giannantonio M. The potential of pregabalin in neurology, psychiatry and addiction: a qualitative overview. Curr Pharm Des. 2013;19(35):6367-74. doi: 10.2174/13816128113199990425.
- Background Martinotti G, Di Nicola M, Tedeschi D, Andreoli S, Reina D, Pomponi M, Mazza M, Romanelli R, Moroni N, De Filippis R, Di Giannantonio M, Pozzi G, Bria P, Janiri L. Pregabalin versus naltrexone in alcohol dependence: a randomised, double-blind, comparison trial. J Psychopharmacol. 2010 Sep;24(9):1367-74. doi: 10.1177/0269881109102623. Epub 2009 Apr 3.
- Background Mirijello A, Caputo F, Vassallo G, Rolland B, Tarli C, Gasbarrini A, Addolorato G. GABAB Agonists for the Treatment of Alcohol Use Disorder. Curr Pharm Des. 2015;21(23):3367-72. doi: 10.2174/1381612821666150619091858.
- Background Oulis P, Konstantakopoulos G. Efficacy and safety of pregabalin in the treatment of alcohol and benzodiazepine dependence. Expert Opin Investig Drugs. 2012 Jul;21(7):1019-29. doi: 10.1517/13543784.2012.685651. Epub 2012 May 9.
- Background Oulis P, Konstantakopoulos G. Pregabalin in the treatment of alcohol and benzodiazepines dependence. CNS Neurosci Ther. 2010 Spring;16(1):45-50. doi: 10.1111/j.1755-5949.2009.00120.x.
- Background Pae CU, Marks DM, Han C, Masand PS, Patkar AA. Pregabalin augmentation of antidepressants in patients with accident-related posttraumatic stress disorder: an open label pilot study. Int Clin Psychopharmacol. 2009 Jan;24(1):29-33. doi: 10.1097/YIC.0b013e32831feea9.
- Background Shorter D, Hsieh J, Kosten TR. Pharmacologic management of comorbid post-traumatic stress disorder and addictions. Am J Addict. 2015 Dec;24(8):705-12. doi: 10.1111/ajad.12306. Epub 2015 Nov 20.
- Background Strawn JR, Dowling BP, Geracioti TD Jr. Pregabalin treatment of posttraumatic stress disorder. J Clin Psychopharmacol. 2008 Oct;28(5):596-7. doi: 10.1097/JCP.0b013e318184c8f2. No abstract available.
- Wheeler PB, Mackey CD, Moskal D, Brady DJ, Foster KT, Marks RM, Dickerson DL, Kelly DL, Bennett ME, Roche DJO. Religiosity and the relationship between sexual trauma, alcohol use, and sleep quality: a moderated mediation model. Alcohol Alcohol. 2025 May 14;60(4):agaf030. doi: 10.1093/alcalc/agaf030.
- Moskal D, Bennett ME, Marks RM, Roche DJO. Associations among Trauma Exposure, Post-Traumatic Stress Symptoms and Alcohol Use in Black/African American Treatment-Seeking Adults. J Dual Diagn. 2024 Jan-Mar;20(1):5-15. doi: 10.1080/15504263.2023.2286025. Epub 2024 Feb 1.
- Marks RM, Bennett ME, Williams JBW, DuMez EL, Roche DJO. SIGH, what's in a name? An examination of the factor structure and criterion validity of the (Structured Interview Guide for the) Hamilton Anxiety scale (SIGH-A) in a sample of African American adults with co-occurring trauma experience and heavy alcohol use. Exp Clin Psychopharmacol. 2022 Dec;30(6):841-852. doi: 10.1037/pha0000508. Epub 2021 Jul 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pregabalin | Small molecule | 450 mg | Oral |