Exercise to Improve Outcomes of Treatment for Methamphetamine Users

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Richard Rawson, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01103531
First received: March 31, 2010
Last updated: November 30, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention
Addiction
Behavioral: Aerobic and Resistance Exercise
Behavioral: Educational information about health topics

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aerobic Exercise to Improve Outcomes of Treatment for Methamphetamine Dependence

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Self-reported Days of Methamphetamine Use [ Time Frame: over the 12 week follow-up period ] [ Designated as safety issue: No ]
    The primary efficacy measure will be days of self-reported MA use over the 12 weeks after discharge.


Secondary Outcome Measures:
  • Overall Physical Health [ Time Frame: 12-week follow-up period ] [ Designated as safety issue: No ]
    The effect of the interventions will be compared between the Exercise and Education groups using generalized regression for repeated measures on each of the test results from baseline to discharge to 12 weeks post-discharge

  • Brain-Imaging Data [ Time Frame: End of intervention (9 weeks) ] [ Designated as safety issue: No ]
    To examine pre- to post-intervention differences in D2/D3 receptor availability a repeated-measures ANOVA will be performed using the binding potential for [18F]fallypride in subcortical regions of interest.

  • Psychiatric Symptoms [ Time Frame: 12 week follow-up period ] [ Designated as safety issue: No ]
    The effect of the interventions will be compared with repeated measures analysis from baseline to discharge to 12 and 26 weeks after discharge.


Enrollment: 135
Study Start Date: March 2010
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: Aerobic and Resistance Exercise
Aerobic and resistance exercise for 24 exercise training sessions over an 8-week period (three times weekly).
Active Comparator: 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.
Behavioral: 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.

Detailed Description:

Participants were recruited to the study using various methods, including word of mouth and IRB-approved flyers posted throughout the treatment facility. Onsite study staff screened MA-dependent clients in a private study office and reviewed the informed consent protocol. After completion of informed consent procedures, participants entered a1-2week screening phase to determine eligibility, consisting of medical history, physical exam, laboratory studies, and ECG. Eligible clients were taken through study baseline assessments to inform randomization to study conditions, either an exercise intervention or health education control, using a computerized urn randomization program that stratified clients to conditions based on gender (male/female) and severity of baseline MA use (higher vs. lower severity). The cut-off point for determining lower severity MA use versus higher severity use was identified using data from previous clinical outcome studies that show the median number of days of MA use ranges from16 to 20 days at treatment entry. Hence, we defined "lower severity" as using MA for 18 or fewer days in the previous month, and "higher severity" as using for 19 or more days in the past month. The study's data management center (DMC) maintained the urn randomization program and the records that linked participant identification numbers to study condition. Study interventions were conducted onsite while participants were enrolled in usual care at the residential treatment facility; cases of early discharge from the facility resulted in premature termination from the study.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be seeking treatment for their MA dependence;
  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:

  1. Clinically significant heart disease or hypertension; unstable pulmonary or cardiovascular disease that would interfere with participation in exercise regimen
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103531

Locations
United States, California
Cri-Help, Inc
North Hollywood, California, United States, 91601
Sponsors and Collaborators
University of California, Los Angeles
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Richard Rawson, PhD UCLA Integrated Substance Abuse Programs
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Richard Rawson, Professor and Associate Director, UCLA Integrated Substance Abuse Programs, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01103531     History of Changes
Other Study ID Numbers: 09-08-099  1R01DA027633 
Study First Received: March 31, 2010
Last Updated: November 30, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Methamphetamine
Methamphetamine Dependence
Methamphetamine Treatment
Aerobic Exercise
Resistance Exercise
Brain Imaging
D2 and D3 receptor availability

Additional relevant MeSH terms:
Methamphetamine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Autonomic Agents
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2016