Stimulant Abuse and Dependence
Conditions
Brief summary
The purpose of this study is to investigate if health interventions (intensive exercise or health education) can be used to help improve substance abuse treatment. The primary objective of this protocol is to compare percent days of abstinence between Vigorous Intensity High Dose exercise (VIHD) and Health Education Intervention (HEI) groups based on stimulant (i.e., cocaine, methamphetamine, amphetamine, or other stimulant, excluding caffeine and nicotine) use during a 12-week acute phase.
Detailed description
This study is designed as a two-group, randomized controlled trial to test the effectiveness of the addition of exercise and health education to treatment as usual in improving drug treatment outcomes in 330 eligible and interested participants who provide informed consent at 8-10 sites across the nation. These participants will be randomized to one of two treatment arms: (1) Vigorous Intensity High Dose Exercise Augmentation (VIHD): Usual Care Augmented with Vigorous Intensity High Dose Exercise or (2) Health Education Intervention Augmentation (HEI): Usual Care Augmented with Health Education. This study will include individuals diagnosed with stimulant abuse or dependence (cocaine, methamphetamine, amphetamine or other stimulant, except caffeine or nicotine) who begin treatment while in a residential setting.
Interventions
OTHERVigorous Intensity High Dose Exercise
Participants randomized to the exercise condition will begin with supervised exercise 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. Vigorous intensity high dose exercise will be prescribed at a dose of 12 kcal/kg/week (KKW), with intensity ranging from 70-85% maximal heart rate.
Participants randomized to the health education condition will also begin with visits 3 times per week during the 12-week acute phase. The health education sessions will be conducted as one-on-one (i.e., individual) sessions. Health education sessions will consist of information on health-related topics distributed via methods such as didactics, audio and video materials, and written materials.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female age 18-65. * Admitted to residential setting and receiving substance use treatment. * Ability to understand and willingness to provide written informed consent. * Agree to remain in facility for authorized treatment of about 21-30 days. * Willing to provide contact information. * Self-reported use of stimulant drug (cocaine, methamphetamine, amphetamine, or other stimulant, excluding caffeine and nicotine) within the 30 days prior to admission for treatment. * Meets DSM-IV criteria for substance abuse or dependence for stimulants (cocaine, methamphetamine, amphetamine, or other stimulant, excluding caffeine and nicotine) within the last 12 months. * Medical clearance with protocol-defined stress testing (in accordance with American College of Sports Medicine (ACSM) guidelines) from protocol approved medical personnel. Details of guidelines and related testing protocol are provided in the study Manual of Procedures. * Body mass index (BMI)≤40 kg/m2 or BMI 40 \>kg/m2 and cleared by medical personnel to exercise. * Able to comprehend and communicate in English.
Exclusion criteria
* Evidence of general medical condition or other abnormality that contraindicates use of exercise, based on the Medical Screening Visit. * Current opiate dependence. * Currently considered a high suicide risk and/or high risk for being unable to complete the study due to the need for psychiatric hospitalization, suicide attempts or suicidality, significant self-mutilation, or other self-injurious or destructive behavior based on the judgment of the site PI, medical personnel, or designee. * Pregnancy. * Significant physical activity, defined as aerobic exercise more than 3 times per week for 20 minutes or more, completed consistently for the three months prior to study enrollment. * Current psychotic disorder. Other comorbid psychiatric diagnosis that, in the investigator's judgment, will pose a safety issue or make it difficult for the participant to understand or complete the intervention. * Concomitant treatments: beta blockers; methadone, buprenorphine, or any other opioid replacement therapies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Days Abstinent | single value calculated based on TLFB data during days 22-84 | Percent days of abstinence based on stimulant (i.e., cocaine, methamphetamine, amphetamine, or other stimulant, excluding caffeine and nicotine) use during the 12-week acute phase. Days of abstinence will be measured during days 22-84, since it is anticipated that most individuals will be in a highly structured environment during the first 21 days of the study, and therefore would have little opportunity to use substances (i.e., the groups are not likely to differ during this time period). Measured by the Timeline Follow Back (TLFB) and aided by urine drug screen collected three times/week. |
Secondary
| Measure | Time frame |
|---|---|
| Withdrawal Symptoms as Measured by the Stimulant Selective Severity Assessment (SSSA) and Craving as Measured by the Stimulant Craving Questionnaire-Brief (STCQ-Brief) | 12 weeks |
| Drug Use and Related Outcomes for All Substances (Categorized as Alcohol, Cannabinoids, Nicotine, Opioids, or Sedative/Hypnotic/Anxiolytics) | 12 weeks |
| Time to Relapse (Defined as Second Positive Urine Test [for Stimulants] and Use of Drugs Established by TLFB) | 12 weeks |
| Drug Use and Related Outcomes During the Entire Course of the Study (i.e., Randomization to 9 Months) | 9 months |
| Examination of Additional Health Benefits (in Sleep, Cognitive Function, Mood, Quality of Life and Anhedonia, and Weight Gain) | 9 months |
| Time to Dropout From Substance Abuse Treatment | 12 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vigorous Intensity High Dose Exercise Usual Care Augmented with Vigorous Intensity High Dose Exercise
Vigorous Intensity High Dose Exercise: Participants randomized to the exercise condition will begin with supervised exercise 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. Vigorous intensity high dose exercise will be prescribed at a dose of 12 kcal/kg/week (KKW), with intensity ranging from 70-85% maximal heart rate. | 152 |
| Health Education Intervention Health Education Intervention
Health Education Intervention: Participants randomized to the health education condition will also begin with visits 3 times per week during the 12-week acute phase. The health education sessions will be conducted as one-on-one (i.e., individual) sessions. Health education sessions will consist of information on health-related topics distributed via methods such as didactics, audio and video materials, and written materials. | 150 |
| Total | 302 |
Baseline characteristics
| Characteristic | Health Education Intervention | Vigorous Intensity High Dose Exercise | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 150 Participants | 152 Participants | 302 Participants |
| Age, Continuous | 39.5 years STANDARD_DEVIATION 11 | 38.5 years STANDARD_DEVIATION 10 | 39 years STANDARD_DEVIATION 10.5 |
| Region of Enrollment United States | 150 Participants | 152 Participants | 302 Participants |
| Sex: Female, Male Female | 58 Participants | 63 Participants | 121 Participants |
| Sex: Female, Male Male | 92 Participants | 89 Participants | 181 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 79 / 152 | 28 / 150 |
| serious Total, serious adverse events | 19 / 152 | 21 / 150 |
Outcome results
Primary
Percent Days Abstinent
Percent days of abstinence based on stimulant (i.e., cocaine, methamphetamine, amphetamine, or other stimulant, excluding caffeine and nicotine) use during the 12-week acute phase. Days of abstinence will be measured during days 22-84, since it is anticipated that most individuals will be in a highly structured environment during the first 21 days of the study, and therefore would have little opportunity to use substances (i.e., the groups are not likely to differ during this time period). Measured by the Timeline Follow Back (TLFB) and aided by urine drug screen collected three times/week.
Time frame: single value calculated based on TLFB data during days 22-84
Population: Mean percent stimulant abstinence days based on Timeline Follow back and Eliminate Contradiction (ELCON) algorithm adjustment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vigorous Intensity High Dose Exercise | Percent Days Abstinent | Timeline Follow Back (TLFB) | 90.8 Percentage of Days | Standard Deviation 16.4 |
| Vigorous Intensity High Dose Exercise | Percent Days Abstinent | ELCON algorithm | 75.5 Percentage of Days | Standard Deviation 27.4 |
| Health Education Intervention | Percent Days Abstinent | Timeline Follow Back (TLFB) | 91.6 Percentage of Days | Standard Deviation 14.7 |
| Health Education Intervention | Percent Days Abstinent | ELCON algorithm | 77.2 Percentage of Days | Standard Deviation 25.1 |
p-value: <0.05Linear mixed effects model
Secondary
Drug Use and Related Outcomes During the Entire Course of the Study (i.e., Randomization to 9 Months)
Time frame: 9 months
Secondary
Drug Use and Related Outcomes for All Substances (Categorized as Alcohol, Cannabinoids, Nicotine, Opioids, or Sedative/Hypnotic/Anxiolytics)
Time frame: 12 weeks
Secondary
Examination of Additional Health Benefits (in Sleep, Cognitive Function, Mood, Quality of Life and Anhedonia, and Weight Gain)
Time frame: 9 months
Secondary
Time to Dropout From Substance Abuse Treatment
Time frame: 12 weeks
Secondary
Time to Relapse (Defined as Second Positive Urine Test [for Stimulants] and Use of Drugs Established by TLFB)
Time frame: 12 weeks
Secondary
Withdrawal Symptoms as Measured by the Stimulant Selective Severity Assessment (SSSA) and Craving as Measured by the Stimulant Craving Questionnaire-Brief (STCQ-Brief)
Time frame: 12 weeks