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2. Stimulant Reduction Intervention using Dosed Exercise (STRIDE) - CTN 0037: study protocol for a randomized controlled trial

Author

Trivedi, Madhukar H, Greer, Tracy L, Grannemann, Bruce D, Church, Timothy S, Somoza, Eugene, Blair, Steven N, Szapocznik, Jose, Stoutenberg, Mark, Rethorst, Chad, Warden, Diane, Ring, Kolette M, Walker, Robrina, Morris, David W, Kosinski, Andrzej S, Kyle, Tiffany, Marcus, Bess, Crowell, Becca, Oden, Neal, and Nunes, Edward

Abstract

Abstract Background There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE) study. Methods/Design STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI) or Health Education Intervention Augmentation (HEI). Both groups will receive TAU (i.e., usual care). The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual) sessions, although other participants may be exercising at the same time. Following the 12-week acute phase, participants will begin a 6-month continuation phase during which time they will attend one weekly supervised DEI or HEI session. Clinical Trials Registry ClinicalTrials.gov, NCT01141608 http://clinicaltrials.gov/ct2/show/NCT01141608?term=Stimulant+Reduction+Intervention+using+Dosed+Exercise&rank=1

Published
2011

5. Predictors of Abstinence: National Institute of Drug Abuse Multisite Buprenorphine/Naloxone Treatment Trial in Opioid-Dependent Youth

Author

Subramaniam, Geetha A., Warden, Diane, and Minhajuddin, Abu

Abstract

Objective: To examine predictors of opioid abstinence in buprenorphine/naloxone (Bup/Nal)-assisted psychosocial treatment for opioid-dependent youth. Method: Secondary analyses were performed of data from 152 youth (15-21 years old) randomly assigned to 12 weeks of extended Bup/Nal therapy or up to 2 weeks of Bup/Nal detoxification with weekly individual and group drug counseling. Logistic regression models were constructed to identify baseline and during-treatment predictors of opioid-positive urine (OPU) at week 12. Predictors were selected based on significance or trend toward significance (i.e., p less than 0.1), and backward stepwise selection was used, controlling for treatment group, to produce final independent predictors at p less than or equal to 0.05. Results: Youth presenting to treatment with previous 30-day injection drug use and more active medical/psychiatric problems were less likely to have a week-12 OPU. Those with early treatment opioid abstinence (i.e., weeks 1 and 2) and those who received additional nonstudy treatments during the study were less likely to have a week-12 OPU and those not completing 12 weeks of treatment were more likely to have an OPU. Conclusions: Youth with advanced illness (i.e., reporting injection drug use and additional health problems) and those receiving ancillary treatments to augment study treatment were more likely to have lower opioid use. Treatment success in the first 2 weeks and completion of 12 weeks of treatment were associated with lower rates of OPU. These findings suggest that youth with advanced illness respond well to Bup/Nal treatment and identify options for tailoring treatment for opioid-dependent youth presenting at community-based settings. (Contains 3 tables.)

Published
2011
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11. Randomized comparison of selective serotonin reuptake inhibitor (escitalopram) monotherapy and antidepressant combination pharmacotherapy for major depressive disorder with melancholic features: A CO-MED report

Author

Bobo, William V., Chen, Helen, Trivedi, Madhukar H., Stewart, Jonathan W., Nierenberg, Andrew A., Fava, Maurizio, Kurian, Benji T., Warden, Diane, Morris, David W., Luther, James F., Husain, Mustafa M., Cook, Ian A., Lesser, Ira M., Kornstein, Susan G., Wisniewski, Stephen R., Rush, A. John, and Shelton, Richard C.

Published
2011
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19. Selecting among second-step antidepressant medication monotherapies

Author

Rush, A. John, Wisniewski, Stephen R., Warden, Diane, Luther, James F., Davis, Lori L., Fava, Maurizio, Nierenberg, Andrew A., and Trivedi, Madhukar H.

Subjects
Antidepressants -- Dosage and administration, Antidepressants -- Research, Major depressive disorder -- Drug therapy, Health, Psychology and mental health
Published
2008

21. Major depression symptoms in primary care and psychiatric care settings: a cross-sectional analysis

Author

Gaynes, Bradley N., Rush, A. John, Trivedi, Madhukar H., Wisniewski, Stephen R., Balasubramani, G.K., Spencer, Donald C., Petersen, Timothy, Klinkman, Michael, Warden, Diane, Nicholas, Linda, and Fava, Maurizio

Subjects
Bristol-Myers Squibb Co., Eli Lilly and Co., Pharmaceutical industry -- Surveys, Pharmaceutical industry -- Health aspects, Clinical psychiatry -- Surveys, Clinical psychiatry -- Health aspects, Public sector -- Surveys, Public sector -- Health aspects, Major depressive disorder -- Development and progression, Major depressive disorder -- Care and treatment, Major depressive disorder -- Risk factors, Major depressive disorder -- Surveys, Major depressive disorder -- Health aspects, Medical research -- Surveys, Medical research -- Health aspects, Medicine, Experimental -- Surveys, Medicine, Experimental -- Health aspects, Mental health -- Surveys, Mental health -- Health aspects, Family medicine -- Surveys, Family medicine -- Health aspects, Clinical trials -- Surveys, Clinical trials -- Health aspects, Serotonin uptake inhibitors -- Surveys, Serotonin uptake inhibitors -- Health aspects, Diabetes therapy -- Surveys, Diabetes therapy -- Health aspects, Comorbidity -- Development and progression, Comorbidity -- Care and treatment, Comorbidity -- Risk factors, Comorbidity -- Surveys, Comorbidity -- Health aspects, Anxiety -- Development and progression, Anxiety -- Care and treatment, Anxiety -- Risk factors, Anxiety -- Surveys, Anxiety -- Health aspects, Pain -- Care and treatment, Pain -- Surveys, Pain -- Health aspects, Health, Science and technology
Published
2007

23. Bupropion-SR, sertraline, or venlafaxine-XR after failure of SSRIs for depression

Author

Rush, A. John, Trivedi, Madhukar H., Wisniewski, Stephen R., Stewart, Jonathan W., Nierenberg , Andrew A., Thase, Michael E., Ritz, Louise, Warden, Diane, Luther, James F., Shores-Wilson, Kathy, Niederehe, George, and Fava, Maurizio

Subjects
Depression, Mental -- Drug therapy, Serotonin uptake inhibitors -- Dosage and administration, Citalopram -- Dosage and administration, Bupropion -- Dosage and administration, Sertraline -- Dosage and administration, Venlafaxine -- Dosage and administration, Clinical trials
Abstract

The Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial used an equipoise stratified, randomized design to evaluate the relative efficacy and tolerability of various antidepressant treatments for outpatients with nonpsychotic major depressive disorder who had a lack of remission or could not tolerate the selective serotonin-reuptake inhibitor (SSRI) citalopram. After unsuccessful treatment with a SSRI, approximately one in four patients had a remission of symptoms after switching to another antidepressant.

Published
2006

26. Assessing anxious features in depressed outpatients

Author

McClintock, Shawn M., Husain, Mustafa M., Bernstein, Ira H., Wisniewski, Stephen R., Trivedi, Madhukar H., Morris, David, Alpert, Jonathan, Warden, Diane, Luther, James F., Kornstein, Susan G., Biggs, Melanie M., Fava, Maurizio, and Rush, John A.

Published
2011
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47. Stimulant Reduction Intervention using Dosed Exercise (STRIDE) - CTN 0037: Study protocol for a randomized controlled trial

Author

Morris David W, Walker Robrina, Ring Kolette M, Warden Diane, Rethorst Chad, Stoutenberg Mark, Szapocznik Jose, Blair Steven N, Somoza Eugene, Church Timothy S, Grannemann Bruce D, Greer Tracy L, Trivedi Madhukar H, Kosinski Andrzej S, Kyle Tiffany, Marcus Bess, Crowell Becca, Oden Neal, and Nunes Edward

Subjects
stimulant abuse, stimulant dependence, exercise, health education, behavioral intervention, Medicine (General), R5-920
Abstract

Abstract Background There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE) study. Methods/Design STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI) or Health Education Intervention Augmentation (HEI). Both groups will receive TAU (i.e., usual care). The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual) sessions, although other participants may be exercising at the same time. Following the 12-week acute phase, participants will begin a 6-month continuation phase during which time they will attend one weekly supervised DEI or HEI session. Clinical Trials Registry ClinicalTrials.gov, NCT01141608 http://clinicaltrials.gov/ct2/show/NCT01141608?term=Stimulant+Reduction+Intervention+using+Dosed+Exercise&rank=1

Published
2011
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49. Randomized Controlled Trial Comparing Exercise to Health Education for Stimulant Use Disorder

Author

Trivedi, Madhukar H., primary, Greer, Tracy L., additional, Rethorst, Chad D., additional, Carmody, Thomas, additional, Grannemann, Bruce D., additional, Walker, Robrina, additional, Warden, Diane, additional, Shores-Wilson, Kathy, additional, Stoutenberg, Mark, additional, Oden, Neal, additional, Silverstein, Meredith, additional, Hodgkins, Candace, additional, Love, Lee, additional, Seamans, Cindy, additional, Stotts, Angela, additional, Causey, Trey, additional, Szucs-Reed, Regina P., additional, Rinaldi, Paul, additional, Myrick, Hugh, additional, Straus, Michele, additional, Liu, David, additional, Lindblad, Robert, additional, Church, Timothy, additional, Blair, Steven N., additional, and Nunes, Edward V., additional

Published
2017
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50. Rationale for Using Exercise in the Treatment of Stimulant Use Disorders

Author

Greer, Tracy L., Ring, Kolette M., Warden, Diane, Grannemann, Bruce D., Church, Timothy S., Somoza, Eugene, Blair, Steven N., Szapocznik, Jose, Stoutenberg, Mark, Rethorst, Chad, Walker, Robrina, Morris, David W., Kosinski, Andrzej S., Kyle, Tiffany, Marcus, Bess, Crowell, Becca, Oden, Neal, Nunes, Edward, and Trivedi, Madhukar H.

Subjects
Article
Abstract

Novel approaches to the treatment of stimulant abuse and dependence are needed. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse. In addition, exercise has been associated with improvements in many other health-related areas that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight, quality of life, and anhedonia. Neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes in stimulant abuse. The National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE) study is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. If effective, exercise may provide an additional approach to the treatment of stimulant use disorders.

Published
2012

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