Exercise to Improve Outcomes of Treatment for Methamphetamine Users
Condition: Addiction
MeSH terms: Behavior, Addictive
Study type: Interventional

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.
    

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.
    

Intervention name(s): Aerobic and Resistance Exercise; Educational information about health topics
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Aerobic and resistance exercise for 24 exercise training sessions over an 8-week period (three times weekly).; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Methamphetamine; Methamphetamine Dependence; Methamphetamine Treatment; Aerobic Exercise; Resistance Exercise; Brain Imaging; D2 and D3 receptor availability