Exercise to Improve Outcomes of Treatment for Methamphetamine Users
NCT ID: NCT01103531
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
135 participants
INTERVENTIONAL
2010-03-31
2015-07-31
Brief Summary
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Detailed Description
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Participants randomized to the exercise condition received a structured exercise program 3 times a week for 8 weeks. Exercise sessions consisted of a 5-min warm-up, 30 min of aerobic activity on a treadmill, followed by 15 min of weight training and a 5-min cool-down/stretching period. Each session was monitored by a staff exercise physiologist who guided one to two participants at a time. Using heart rate monitors, the exercise physiologist worked closely with each individual participant on exercise days to increase treadmill speed/slope to maintain a heart rate between 60% and 85% of maximum for 30 minutes. Once a participant was able to complete two sets of 15 repetitions of any given exercise, weight was incrementally increased.
A data collection protocol occurred at baseline, and also weekly during the 8-week study period, at termination of the study period, and at 1-, 3-, and 6-months post treatment from the residential program (approximately 7-10 days following completion of the intervention period). Participants were compensated $40 per data collection session.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Exercise Group
Participants in this group will be scheduled for 24 exercise training sessions over an 8-week period (three times weekly) and will be supervised by a certified exercise physiologist.
Aerobic and Resistance Exercise
Aerobic and resistance exercise for 24 exercise training sessions over an 8-week period (three times weekly).
Education Group
Participants in this group will meet with a counselor who will present and discuss information that includes topics on health and wellness, and lifestyle topics such as healthy eating, meditation, sleep hygiene, and cancer screening.
Educational information about health topics
A counselor will meet with participants for 24 sessions (3 times/week) over an 8-week period to present and discuss information that includes topics on health and wellness, and lifestyle topics such as healthy eating, meditation, sleep hygiene, and cancer screening.
Interventions
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Aerobic and Resistance Exercise
Aerobic and resistance exercise for 24 exercise training sessions over an 8-week period (three times weekly).
Educational information about health topics
A counselor will meet with participants for 24 sessions (3 times/week) over an 8-week period to present and discuss information that includes topics on health and wellness, and lifestyle topics such as healthy eating, meditation, sleep hygiene, and cancer screening.
Eligibility Criteria
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Inclusion Criteria
2. Be 18 years of age or older, and 45 or younger for males, 55 or younger for females;
3. Meet DSM-IV-TR criteria for MA dependence;
4. Have vital signs that are within clinically acceptable normal range, e.g., resting pulse between 50 and 90 /min, blood pressures between 85-150mm Hg systolic and 45-90mm Hg diastolic;
5. Have a medical history and physical examination that, in the judgment of the study physician or Principal Investigator, show no clinically significant contraindications for study participation;
6. For females, provide negative pregnancy urine tests before randomization (and for the sub-sample, another negative test before the final PET scan at the conclusion of the intervention).
Exclusion Criteria
2. Neurological or psychiatric disorders as assessed by MINI or clinical interview, such as psychosis, bipolar illness, Tourette's syndrome, major depression, organic brain disease, dementia, or any other neuro-psychiatric disorder that would require ongoing treatment or that would make study compliance difficult;
3. Musculoskeletal disease that would prevent participation in exercise regimen
4. Baseline ECG showing evidence of cardiac ischemia, arrhythmia, or other clinically significant abnormalities
5. Untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease (other than HIV) that requires immediate medical attention;
6. Clinically significant abnormalities in hematology and chemistry laboratory tests that may make participation hazardous;
7. Have HIV and unable to obtain a clearance for participation from his/her AIDS medical care provider;
8. Pregnant;
9. Any other illness, condition, or use of medications that, in the opinion of the PI and/or the study physician, would preclude safe participation or completion of the study.
18 Years
55 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of California, Los Angeles
OTHER
Responsible Party
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Richard Rawson
Professor and Associate Director, UCLA Integrated Substance Abuse Programs
Principal Investigators
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Richard Rawson, PhD
Role: PRINCIPAL_INVESTIGATOR
UCLA Integrated Substance Abuse Programs
Locations
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Cri-Help, Inc
North Hollywood, California, United States
Countries
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References
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Cooper CB. Exercise in chronic pulmonary disease: aerobic exercise prescription. Med Sci Sports Exerc. 2001 Jul;33(7 Suppl):S671-9. doi: 10.1097/00005768-200107001-00005.
Fonkalsrud EW, Mendoza J, Finn PJ, Cooper CB. Recent experience with open repair of pectus excavatum with minimal cartilage resection. Arch Surg. 2006 Aug;141(8):823-9. doi: 10.1001/archsurg.141.8.823.
Glasner-Edwards S, Mooney LJ, Marinelli-Casey P, Hillhouse M, Ang A, Rawson R; Methamphetamine Treatment Project Corporate Authors. Clinical course and outcomes of methamphetamine-dependent adults with psychosis. J Subst Abuse Treat. 2008 Dec;35(4):445-50. doi: 10.1016/j.jsat.2007.12.004. Epub 2008 Feb 21.
Glasner-Edwards S, Mooney LJ, Marinelli-Casey P, Hillhouse M, Ang A, Rawson R; Methamphetamine Treatment Project. Identifying methamphetamine users at risk for major depressive disorder: findings from the methamphetamine treatment project at three-year follow-up. Am J Addict. 2008 Mar-Apr;17(2):99-102. doi: 10.1080/10550490701861110.
Glasner-Edwards S, Mooney LJ, Marinelli-Casey P, Hillhouse M, Ang A, Rawson R; Methamphetamine Treatment Project. Risk factors for suicide attempts in methamphetamine-dependent patients. Am J Addict. 2008 Jan-Feb;17(1):24-7. doi: 10.1080/10550490701756070.
Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1423-34. doi: 10.1249/mss.0b013e3180616b27.
Lautenschlager NT, Cox KL, Flicker L, Foster JK, van Bockxmeer FM, Xiao J, Greenop KR, Almeida OP. Effect of physical activity on cognitive function in older adults at risk for Alzheimer disease: a randomized trial. JAMA. 2008 Sep 3;300(9):1027-37. doi: 10.1001/jama.300.9.1027.
Malek MH, Fonkalsrud EW, Cooper CB. Ventilatory and cardiovascular responses to exercise in patients with pectus excavatum. Chest. 2003 Sep;124(3):870-82. doi: 10.1378/chest.124.3.870.
Monterosso JR, Ainslie G, Xu J, Cordova X, Domier CP, London ED. Frontoparietal cortical activity of methamphetamine-dependent and comparison subjects performing a delay discounting task. Hum Brain Mapp. 2007 May;28(5):383-93. doi: 10.1002/hbm.20281.
Palmer JA, Palmer LK, Michiels K, Thigpen B. Effects of type of exercise on depression in recovering substance abusers. Percept Mot Skills. 1995 Apr;80(2):523-30. doi: 10.2466/pms.1995.80.2.523.
Rawson RA, Anglin MD, Ling W. Will the methamphetamine problem go away? J Addict Dis. 2002;21(1):5-19. doi: 10.1300/j069v21n01_02.
Rawson RA, Marinelli-Casey P, Anglin MD, Dickow A, Frazier Y, Gallagher C, Galloway GP, Herrell J, Huber A, McCann MJ, Obert J, Pennell S, Reiber C, Vandersloot D, Zweben J; Methamphetamine Treatment Project Corporate Authors. A multi-site comparison of psychosocial approaches for the treatment of methamphetamine dependence. Addiction. 2004 Jun;99(6):708-17. doi: 10.1111/j.1360-0443.2004.00707.x.
Simon SL, Domier C, Carnell J, Brethen P, Rawson R, Ling W. Cognitive impairment in individuals currently using methamphetamine. Am J Addict. 2000 Summer;9(3):222-31. doi: 10.1080/10550490050148053.
Simon SL, Domier CP, Sim T, Richardson K, Rawson RA, Ling W. Cognitive performance of current methamphetamine and cocaine abusers. J Addict Dis. 2002;21(1):61-74. doi: 10.1300/j069v21n01_06.
Skrede A, Munkvold H, Watne O, Martinsen EW. [Exercise contacts in the treatment of substance dependence and mental disorders]. Tidsskr Nor Laegeforen. 2006 Aug 10;126(15):1925-7. Norwegian.
Marques-Magallanes JA, Koyal SN, Cooper CB, Kleerup EC, Tashkin DP. Impact of habitual cocaine smoking on the physiologic response to maximum exercise. Chest. 1997 Oct;112(4):1008-16. doi: 10.1378/chest.112.4.1008.
Salem BA, Gonzales-Castaneda R, Ang A, Rawson RA, Dickerson D, Chudzynski J, Penate J, Dolezal B, Cooper CB, Mooney LJ. Craving among individuals with stimulant use disorder in residential social model-based treatment - Can exercise help? Drug Alcohol Depend. 2022 Feb 1;231:109247. doi: 10.1016/j.drugalcdep.2021.109247. Epub 2021 Dec 31.
Rawson RA, Chudzynski J, Mooney L, Gonzales R, Ang A, Dickerson D, Penate J, Salem BA, Dolezal B, Cooper CB. Impact of an exercise intervention on methamphetamine use outcomes post-residential treatment care. Drug Alcohol Depend. 2015 Nov 1;156:21-28. doi: 10.1016/j.drugalcdep.2015.08.029. Epub 2015 Sep 3.
Mooney LJ, Cooper C, London ED, Chudzynski J, Dolezal B, Dickerson D, Brecht ML, Penate J, Rawson RA. Exercise for methamphetamine dependence: rationale, design, and methodology. Contemp Clin Trials. 2014 Jan;37(1):139-47. doi: 10.1016/j.cct.2013.11.010. Epub 2013 Nov 28.
Other Identifiers
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09-08-099
Identifier Type: -
Identifier Source: org_study_id