Browsing by Author "Sharma, Gaurav"

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Open Access
Bupropion and Naltrexone in Methamphetamine Use Disorder.
(The New England journal of medicine, 2021-01) Trivedi, Madhukar H; Walker, Robrina; Ling, Walter; Dela Cruz, Adriane; Sharma, Gaurav; Carmody, Thomas; Ghitza, Udi E; Wahle, Aimee; Kim, Mora; Shores-Wilson, Kathy; Sparenborg, Steven; Coffin, Phillip; Schmitz, Joy; Wiest, Katharina; Bart, Gavin; Sonne, Susan C; Wakhlu, Sidarth; Rush, A John; Nunes, Edward V; Shoptaw, Steven
Background
The use of naltrexone plus bupropion to treat methamphetamine use disorder has not been well studied.
Methods
We conducted this multisite, double-blind, two-stage, placebo-controlled trial with the use of a sequential parallel comparison design to evaluate the efficacy and safety of extended-release injectable naltrexone (380 mg every 3 weeks) plus oral extended-release bupropion (450 mg per day) in adults with moderate or severe methamphetamine use disorder. In the first stage of the trial, participants were randomly assigned in a 0.26:0.74 ratio to receive naltrexone-bupropion or matching injectable and oral placebo for 6 weeks. Those in the placebo group who did not have a response in stage 1 underwent rerandomization in stage 2 and were assigned in a 1:1 ratio to receive naltrexone-bupropion or placebo for an additional 6 weeks. Urine samples were obtained from participants twice weekly. The primary outcome was a response, defined as at least three methamphetamine-negative urine samples out of four samples obtained at the end of stage 1 or stage 2, and the weighted average of the responses in the two stages is reported. The treatment effect was defined as the between-group difference in the overall weighted responses.
Results
A total of 403 participants were enrolled in stage 1, and 225 in stage 2. In the first stage, 18 of 109 participants (16.5%) in the naltrexone-bupropion group and 10 of 294 (3.4%) in the placebo group had a response. In the second stage, 13 of 114 (11.4%) in the naltrexone-bupropion group and 2 of 111 (1.8%) in the placebo group had a response. The weighted average response across the two stages was 13.6% with naltrexone-bupropion and 2.5% with placebo, for an overall treatment effect of 11.1 percentage points (Wald z-test statistic, 4.53; P<0.001). Adverse events with naltrexone-bupropion included gastrointestinal disorders, tremor, malaise, hyperhidrosis, and anorexia. Serious adverse events occurred in 8 of 223 participants (3.6%) who received naltrexone-bupropion during the trial.
Conclusions
Among adults with methamphetamine use disorder, the response over a period of 12 weeks among participants who received extended-release injectable naltrexone plus oral extended-release bupropion was low but was higher than that among participants who received placebo. (Funded by the National Institute on Drug Abuse and others; ADAPT-2 ClinicalTrials.gov number, NCT03078075.).
Open Access
Corrigendum to "Design of the NIDA clinical trials network validation study of tobacco, alcohol, prescription medications, and substance use/misuse (TAPS) tool" [Contemporary Clinical Trials. 2016 Jul. 19; 50: 90-97].
(Contemp Clin Trials, 2016-11) Wu, Li-Tzy; McNeely, Jennifer; Subramaniam, Geetha A; Sharma, Gaurav; VanVeldhuisen, Paul; Schwartz, Robert P
Open Access
Design of the NIDA clinical trials network validation study of tobacco, alcohol, prescription medications, and substance use/misuse (TAPS) tool.
(Contemporary clinical trials, 2016-09) Wu, Li-Tzy; McNeely, Jennifer; Subramaniam, Geetha A; Sharma, Gaurav; VanVeldhuisen, Paul; Schwartz, Robert P
Substance use and its associated use disorders are under-detected and under-treated in primary care. There is a need for a clinically useful brief screening and assessment instrument to identify primary care patients with substance use, sub-threshold substance use disorder (SUD), and SUD to facilitate brief intervention and treatment.We describe the design of the recently completed National Drug Abuse Treatment Clinical Trials Network's tobacco, alcohol, prescription medications, and substance use/misuse screen and brief assessment tool validation study. Study aims included to: develop a 2-stage screening and brief assessment tool (TAPS Tool) to detect substance use, problem use, and SUD among adult primary care patients; examine the validity of both the screen component and the TAPS Tool by comparing them to reference standard screening and assessment measures of no use, problem use, and SUD; and determine the feasibility and acceptability of the self-administration and interviewer-administration of the tool. The design included a pilot testing phase (n=30) and the main study of 2000 adult primary care participants who were randomly assigned in counter-balanced order to have the interviewer-administration or the self-administration of the TAPS Tool followed by the other administration format. Participants' views of feasibility, acceptability and preference for format of self-administration versus interviewer-administration of the TAPS Tool were assessed. Criterion measures of use and DSM-5 SUDs were administered.The TAPS Tool study builds on prior work to develop a 2-stage clinical tool for facilitating the adoption of screening, brief assessment and treatment for SUDs in primary care.
Open Access
DSM-5 substance use disorders among adult primary care patients: Results from a multisite study.
(Drug and alcohol dependence, 2017-10) Wu, Li-Tzy; McNeely, Jennifer; Subramaniam, Geetha A; Brady, Kathleen T; Sharma, Gaurav; VanVeldhuisen, Paul; Zhu, He; Schwartz, Robert P
BACKGROUND:There are limited data about the extent of DSM-5 substance use disorders (SUDs) among primary care patients. METHODS:This study analyzed data from a multisite validation study of a substance use screening instrument conducted in a diverse sample of 2000 adults aged ≥18 years recruited from five primary care practices in four states. Prevalence and correlates of 12-month DSM-5 SUDs were examined. RESULTS:Overall, 75.5% of the sample used any substance, including alcohol (62.0%), tobacco (44.1%), or illicit drugs/nonmedical medications (27.9%) in the past 12 months (marijuana 20.8%, cocaine 7.3%, opioids 4.8%, sedatives 4.1%, heroin 3.9%). The prevalence of any 12-month SUD was 36.0% (mild disorder 14.2%, moderate/severe disorder 21.8%): tobacco 25.3% (mild 11.5%, moderate/severe 13.8%); alcohol 13.9% (mild 6.9%, moderate/severe 7.0%); and any illicit/nonmedical drug 14.0% (mild 4.0%, moderate/severe 10.0%). Among past 12-month users, a high proportion of tobacco or drug users met criteria for a disorder: tobacco use disorder 57.4% (26.1% mild, 31.3% moderate/severe) and any drug use disorder 50.2% (14.3% mild, 35.8% moderate/severe); a lower proportion of alcohol users (22.4%) met criteria for alcohol use disorder (11.1% mild, 11.3% moderate/severe). Over 80% of adults with opioid/heroin use disorder met criteria for a moderate/severe disorder. Younger ages, male sex, and low education were associated with increased odds of having SUD. CONCLUSION:These findings reveal the high prevalence of SUDs in primary care and underscore the need to identify and address them.
Open Access
Electronic self-administered screening for substance use in adult primary care patients: feasibility and acceptability of the tobacco, alcohol, prescription medication, and other substance use (myTAPS) screening tool
(Addiction Science & Clinical Practice, 2019-12) Adam, Angéline; Schwartz, Robert P; Wu, Li-Tzy; Subramaniam, Geetha; Laska, Eugene; Sharma, Gaurav; Mili, Saima; McNeely, Jennifer
Metadata only
Performance of the Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool for Substance Use Screening in Primary Care Patients.
(Ann Intern Med, 2016-11-15) McNeely, Jennifer; Wu, Li-Tzy; Subramaniam, Geetha; Sharma, Gaurav; Cathers, Lauretta A; Svikis, Dace; Sleiter, Luke; Russell, Linnea; Nordeck, Courtney; Sharma, Anjalee; O'Grady, Kevin E; Bouk, Leah B; Cushing, Carol; King, Jacqueline; Wahle, Aimee; Schwartz, Robert P
Background: Substance use, a leading cause of illness and death, is underidentified in medical practice. Objective: The Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) tool was developed to address the need for a brief screening and assessment instrument that includes all commonly used substances and fits into clinical workflows. The goal of this study was to assess the performance of the TAPS tool in primary care patients. Design: Multisite study, conducted within the National Drug Abuse Treatment Clinical Trials Network, comparing the TAPS tool with a reference standard measure. (ClinicalTrials.gov: NCT02110693). Setting: 5 adult primary care clinics. Participants: 2000 adult patients consecutively recruited from clinic waiting areas. Measurements: Interviewer- and self-administered versions of the TAPS tool were compared with a reference standard, the modified World Mental Health Composite International Diagnostic Interview (CIDI), which measures problem use and substance use disorder (SUD). Results: Interviewer- and self-administered versions of the TAPS tool had similar diagnostic characteristics. For identifying problem use (at a cutoff of 1+), the TAPS tool had a sensitivity of 0.93 (95% CI, 0.90 to 0.95) and specificity of 0.87 (CI, 0.85 to 0.89) for tobacco and a sensitivity of 0.74 (CI, 0.70 to 0.78) and specificity of 0.79 (CI, 0.76 to 0.81) for alcohol. For problem use of illicit and prescription drugs, sensitivity ranged from 0.82 (CI, 0.76 to 0.87) for marijuana to 0.63 (CI, 0.47 to 0.78) for sedatives; specificity was 0.93 or higher. For identifying any SUD (at a cutoff of 2+), sensitivity was lower. Limitations: The low prevalence of some drug classes led to poor precision in some estimates. Research assistants were not blinded to participants' TAPS tool responses when they administered the CIDI. Conclusion: In a diverse population of adult primary care patients, the TAPS tool detected clinically relevant problem substance use. Although it also may detect tobacco, alcohol, and marijuana use disorders, further refinement is needed before it can be recommended broadly for SUD screening. Primary Funding Source: National Institute on Drug Abuse.
Open Access
Proceedings of the 13th annual conference of INEBRIA.
(Addiction science & clinical practice, 2016-09) Watson, Rod; Morris, James; Isitt, John; Barrio, Pablo; Ortega, Lluisa; Gual, Antoni; Conner, Kenneth; Stecker, Tracy; Maisto, Stephen; Paroz, Sophie; Graap, Caroline; Grazioli, Véronique S; Daeppen, Jean-Bernard; Collins, Susan E; Bertholet, Nicolas; McNeely, Jennifer; Kushnir, Vlad; Cunningham, John A; Crombie, Iain K; Cunningham, Kathryn B; Irvine, Linda; Williams, Brian; Sniehotta, Falko F; Norrie, John; Melson, Ambrose; Jones, Claire; Briggs, Andrew; Rice, Peter; Achison, Marcus; McKenzie, Andrew; Dimova, Elena; Slane, Peter W; Grazioli, Véronique S; Collins, Susan E; Paroz, Sophie; Graap, Caroline; Daeppen, Jean-Bernard; Baggio, Stéphanie; Dupuis, Marc; Studer, Joseph; Gmel, Gerhard; Magill, Molly; Grazioli, Véronique S; Tait, Robert J; Teoh, Lucinda; Kelty, Erin; Geelhoed, Elizabeth; Mountain, David; Hulse, Gary K; Renko, Elina; Mitchell, Shannon G; Lounsbury, David; Li, Zhi; Schwartz, Robert P; Gryczynski, Jan; Kirk, Arethusa S; Oros, Marla; Hosler, Colleen; Dusek, Kristi; Brown, Barry S; Finnell, Deborah S; Holloway, Aisha; Wu, Li-Tzy; Subramaniam, Geetha; Sharma, Gaurav; Wallhed Finn, Sara; Andreasson, Sven; Dvorak, Robert D; Kramer, Matthew P; Stevenson, Brittany L; Sargent, Emily M; Kilwein, Tess M; Harris, Sion K; Sherritt, Lon; Copelas, Sarah; Knight, John R; The Partnership for Adolescent Substance Use Research; Mdege, Noreen D; McCambridge, Jim; Bischof, Gallus; Bischof, Anja; Freyer-Adam, Jennis; Rumpf, Hans-Juergen; Fitzgerald, Niamh; Schölin, Lisa; Toner, Paul; Böhnke, Jan R; Veach, Laura J; Currin, Olivia; Dongre, Leigh Z; Miller, Preston R; White, Elizabeth; Williams, Emily C; Lapham, Gwen T; Bobb, Jennifer J; Rubinsky, Anna D; Catz, Sheryl L; Shortreed, Susan; Bensley, Kara M; Bradley, Katharine A; Milward, Joanna; Deluca, Paolo; Khadjesari, Zarnie; Watson, Rod; Fincham-Campbell, Stephanie; Drummond, Colin; Angus, Kathryn; Bauld, Linda; Baumann, Sophie; Haberecht, Katja; Schnuerer, Inga; Meyer, Christian; Rumpf, Hans-Jürgen; John, Ulrich; Gaertner, Beate; Barrault-Couchouron, Marion; Béracochéa, Marion; Allafort, Vincent; Barthélémy, Valérie; Bonnefoi, Hervé; Bussières, Emmanuel; Garguil, Véronique; Auriacombe, Marc; Saint-Jacques, Marianne; Dorval, Michel; M’Bailara, Katia; Segura-Garcia, Lidia; Ibañez-Martinez, Nuria; Mendive-Arbeloa, Juan Manuel; Anoro-Perminger, Manel; Diaz-Gallego, Pako; Piñar-Mateos, Mª Angeles; Colom-Farran, Joan; Deligianni, Marianthi; Yersin, Bertrand; Adam, Angeline; Weisner, Constance; Chi, Felicia; Lu, Wendy; Sterling, Stacy; Kraemer, Kevin L; McGinnis, Kathleen A; Fiellin, David A; Skanderson, Melissa; Gordon, Adam J; Robbins, Jonathan; Zickmund, Susan; Korthuis, P Todd; Edelman, E Jennifer; Hansen, Nathan B; Cutter, Christopher J; Dziura, James; Fiellin, Lynn E; O’Connor, Patrick G; Maisto, Stephen A; Bedimo, Roger; Gilbert, Cynthia; Marconi, Vincent C; Rimland, David; Rodriguez-Barradas, Maria; Simberkoff, Michael; Justice, Amy C; Bryant, Kendall J; Berman, Anne H; Shorter, Gillian W; Bray, Jeremy W; Barbosa, Carolina; Johansson, Magnus; Hester, Reid; Campbell, William; Souza Formigoni, Maria Lucia O; Andrade, André Luzi Monezi; Sartes, Laisa Marcorela Andreoli; Sundström, Christopher; Eék, Niels; Kraepelien, Martin; Kaldo, Viktor; Fahlke, Claudia; Hernandez, Lynn; Becker, Sara J; Jones, Richard N; Graves, Hannah R; Spirito, Anthony; Diestelkamp, Silke; Wartberg, Lutz; Arnaud, Nicolas; Thomasius, Rainer; Gaume, Jacques; Grazioli, Véronique; Fortini, Cristiana; Malan, Zelra; Mash, Bob; Everett-Murphy, Katherine; Grazioli, Véronique S; Studer, Joseph; Mohler-Kuo, M; Bertholet, Nicolas; Gmel, Gerhard; Doi, Lawrence; Cheyne, Helen; Jepson, Ruth; Luna, Vanesa; Echeverria, Leticia; Morales, Silvia; Barroso, Teresa; Abreu, Ângela; Aguiar, Cosma; Stewart, Duncan; Abreu, Angela; Brites, Riany M; Jomar, Rafael; Marinho, Gerson; Parreira, Pedro; Seale, J Paul; Johnson, J Aaron; Henry, Dena; Chalmers, Sharon; Payne, Freida; Tuck, Linda; Morris, Akula; Gonçalves, Cátia; Besser, Bettina; Casajuana, Cristina; López-Pelayo, Hugo; Balcells, María Mercedes; Teixidó, Lídia; Miquel, Laia; Colom, Joan; Hepner, Kimberly A; Hoggatt, Katherine J; Bogart, Andy; Paddock, Susan M; Hardoon, Sarah L; Petersen, Irene; Hamilton, Fiona L; Nazareth, Irwin; White, Ian R; Marston, Louise; Wallace, Paul; Godfrey, Christine; Murray, Elizabeth; Sovinová, Hana; Csémy, Ladislav
Open Access
VALIDATION OF THE 4-ITEM SCREENING COMPONENT OF THE TAPS TOOL TO IDENTIFY UNHEALTHY SUBSTANCE USE AMONG PRIMARY CARE PATIENTS
(JOURNAL OF GENERAL INTERNAL MEDICINE, 2017-04-01) Schwartz, Robert; Gryczynski, Jan; McNeely, Jennifer; Wu, Litzy; Sharma, Gaurav; King, Jacquie; Jelstrom, Eve M; Nordeck, Courtney; Sharma, Anjalee; Mitchell, Shannon; O'Grady, Kevin; Svikis, Dace; Cathers, Lauretta; Subramaniam, Geetha
Open Access
Validation of the TAPS-1: A Four-Item Screening Tool to Identify Unhealthy Substance Use in Primary Care.
(Journal of general internal medicine, 2017-09) Gryczynski, Jan; McNeely, Jennifer; Wu, Li-Tzy; Subramaniam, Geetha A; Svikis, Dace S; Cathers, Lauretta A; Sharma, Gaurav; King, Jacqueline; Jelstrom, Eve; Nordeck, Courtney D; Sharma, Anjalee; Mitchell, Shannon G; O'Grady, Kevin E; Schwartz, Robert P
BACKGROUND:The Tobacco, Alcohol, Prescription Medication, and Other Substance use (TAPS) tool is a combined two-part screening and brief assessment developed for adult primary care patients. The tool's first-stage screening component (TAPS-1) consists of four items asking about past 12-month use for four substance categories, with response options of never, less than monthly, monthly, weekly, and daily or almost daily. OBJECTIVE:To validate the TAPS-1 in primary care patients. DESIGN:Participants completed the TAPS tool in self- and interviewer-administered formats, in random order. In this secondary analysis, the TAPS-1 was evaluated against DSM-5 substance use disorder (SUD) criteria to determine optimal cut-points for identifying unhealthy substance use at three severity levels (problem use, mild SUD, and moderate-to-severe SUD). PARTICIPANTS:Two thousand adult patients at five primary care sites. MAIN MEASURES:DSM-5 SUD criteria were determined via the modified Composite International Diagnostic Interview. Oral fluid was used as a biomarker of recent drug use. KEY RESULTS:Optimal frequency-of-use cut-points on the self-administered TAPS-1 for identifying SUDs were ≥ monthly use for tobacco and alcohol (sensitivity = 0.92 and 0.71, specificity = 0.80 and 0.85, AUC = 0.86 and 0.78, respectively) and any reported use for illicit drugs and prescription medication misuse (sensitivity = 0.93 and 0.89, specificity = 0.85 and 0.91, AUC = 0.89 and 0.90, respectively). The performance of the interviewer-administered format was similar. When administered first, the self-administered format yielded higher disclosure rates for past 12-month alcohol use, illicit drug use, and prescription medication misuse. Frequency of use alone did not provide sufficient information to discriminate between gradations of substance use problem severity. Among those who denied drug use on the TAPS-1, less than 4% had a drug-positive biomarker. CONCLUSIONS:The TAPS-1 can identify unhealthy substance use in primary care patients with a high level of accuracy, and may have utility in primary care for rapid triage.

Browsing by Author "Sharma, Gaurav"

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