Exercise to Improve Outcomes of Treatment for Methamphetamine Users

NCT01103531 | Completed DMC

• 2 other identifiers: 09-08-0991R01DA027633
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effects of an aerobic and strength training exercise program (one that increases the need for oxygen and increases muscle) on the treatment outcomes of 150 individuals in treatment for methamphetamine dependence at Cri-Help. The study will determine if a 60-minute exercise program (three times a week) has an effect (good or bad) on the health and drug use of participants as compared to individuals not participating in an exercise program.

Conditions

Addiction

Keywords

Methamphetamine; Methamphetamine Dependence; Methamphetamine Treatment; Aerobic Exercise; Resistance Exercise; Brain Imaging; D2 and D3 receptor availability

Outcome Measures

Primary Outcomes (1)

• Self-reported Days of Methamphetamine Use

  The primary efficacy measure will be days of self-reported MA use over the 12 weeks after discharge.

  over the 12 week follow-up period

Secondary Outcomes (3)

• Overall Physical Health

  12-week follow-up period

• Brain-Imaging Data

  End of intervention (9 weeks)

• Psychiatric Symptoms

  12 week follow-up period

Study Arms (2)

Exercise Group

EXPERIMENTAL

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.

Behavioral: Aerobic and Resistance Exercise

Education Group

ACTIVE COMPARATOR

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.

Behavioral: Educational information about health topics

Interventions

Aerobic and Resistance Exercise BEHAVIORAL

Aerobic and resistance exercise for 24 exercise training sessions over an 8-week period (three times weekly).

Exercise Group

Educational information about health topics BEHAVIORAL

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.

Education Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be seeking treatment for their MA dependence;
• Be 18 years of age or older, and 45 or younger for males, 55 or younger for females;
• Meet DSM-IV-TR criteria for MA dependence;
• 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;
• 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;
• 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).

You may not qualify if:

• Clinically significant heart disease or hypertension; unstable pulmonary or cardiovascular disease that would interfere with participation in exercise regimen
• 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;
• Musculoskeletal disease that would prevent participation in exercise regimen
• Baseline ECG showing evidence of cardiac ischemia, arrhythmia, or other clinically significant abnormalities
• Untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease (other than HIV) that requires immediate medical attention;
• Clinically significant abnormalities in hematology and chemistry laboratory tests that may make participation hazardous;
• Have HIV and unable to obtain a clearance for participation from his/her AIDS medical care provider;
• Pregnant;
• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Cri-Help, Inc

North Hollywood, California, 91601, United States

Location

Related Publications (19)

• 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.

  PMID: 11462076 BACKGROUND

• 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.

  PMID: 16927491 BACKGROUND

• 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.

  PMID: 18294802 BACKGROUND

• 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.

  PMID: 18393051 BACKGROUND

• 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.

  PMID: 18214719 BACKGROUND

• 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.

  PMID: 17762377 BACKGROUND

• 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.

  PMID: 18768414 BACKGROUND

• 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.

  PMID: 12970011 BACKGROUND

• 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.

  PMID: 16944492 BACKGROUND

• 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.

  PMID: 7675585 BACKGROUND

• 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.

  PMID: 11831500 BACKGROUND

• 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.

  PMID: 15139869 BACKGROUND

• 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.

  PMID: 11000918 BACKGROUND

• 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.

  PMID: 11831501 BACKGROUND

• 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.

  PMID: 16915316 BACKGROUND

• 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.

  PMID: 9377910 BACKGROUND

• 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.

  PMID: 34999268 DERIVED

• 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.

  PMID: 26371404 DERIVED

• 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.

  PMID: 24291456 DERIVED

MeSH Terms

Conditions

Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Richard Rawson, PhD

  UCLA Integrated Substance Abuse Programs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Director, UCLA Integrated Substance Abuse Programs

Study Record Dates

• First Submitted: March 31, 2010
• First Posted: April 14, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

US (1)