Substance Use Disorders
Conditions
Brief summary
This study will continue research designed to improve treatment outcomes for adolescent substance use disorders by integrating neuroscience- and behaviorally-based treatments. In particular, this project will be the first to evaluate whether Working Memory Training can enhance cognitive function and reduce impulsive decision making to improve abstinence outcomes. In addition, an adaptive abstinence-based incentive program will be evaluated as a new method for intervening with those who do not respond to their first-line treatment.
Detailed description
The study will test two novel strategies to enhance outcomes. Working Memory Training (WMT), an efficacious method for strengthening specific cognitive processes, aims to improve factors (e.g., delay discounting / impulsive decision-making) that have shown a strong relation to substance use and treatment response. Second, more intensive and higher magnitude CM (ICM) will be used to motivate abstinence among teens who are not abstinent by Week 4. The investigators hypothesize that these strategies will improve outcomes by modifying a fundamental cognitive system involved in making choices to engage in risky behavior and by increasing motivation to abstain in early nonresponders. Aim 1 will pilot and refine the new procedures in a community clinic in preparation for the randomized trial. A sequential, multiple assignment randomized trial (SMART) will allow the study to determine the most effective first-line treatment and the most effective adaptive strategy (Aim 2). All teens will begin treatment with CM or CM/WMT. After 4 weeks, responders will continue in their first-line treatments, while nonresponders will be randomized to ICM or to continue with first-line treatment. Aim 3 will conduct mechanistic analyses to assess whether cognitive changes related to WMT engender increased abstinence, and whether specific tailoring variables moderate treatment effects. Aim 4 will gather formative data on implementation factors to inform future large-scale studies and dissemination efforts. Primary hypotheses are: (1) first-line treatment with WMT will improve abstinence outcomes and reduce relapse; (2) strategies with ICM for nonresponders will result in better outcomes than those without; (3) WMT will reduce delay discounting, which will predict outcome. The unique approach holds promise for reducing multiple types of risky behaviors by affecting basic mechanisms that determine impulsive decision-making.
Interventions
Multiple group sessions weekly, one individual counseling session weekly with teen to review and discuss contingency management abstinence-based incentives
25 computer-delivered sessions of neurocognitive training
Sponsors
Study design
Eligibility
Inclusion criteria
Participants must be 12 to 26 years of age, must live at home with the parent who will participate, report using marijuana during the previous 30 days or provide a marijuana-positive urine test, meet criteria for cannabis abuse or dependence, and have a parent who can participate.
Exclusion criteria
DSM criteria for dependence (likely to be adjusted for DSM-5 Use Disorder) on alcohol or other drugs other than marijuana (use of or meeting criteria for abuse of other substances will not be an exclusion criterion), active psychosis, severe medical or psychiatric illness limiting participation, or pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Any Cannabis Abstinence | Intervention weeks 1 to 14 | Number of participants with any cannabis abstinence during treatment |
| Weeks of Continuous Cannabis Abstinence | 14 week treatment period | Weeks of continuous abstinence during treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Any Days of Cannabis Use | Intervention weeks 1 to 14 | Number of participants with any days of cannabis use during treatment |
| Days of Cannabis Use | The intervention period between Week 1 and Week 14 | Percent of Days Used During the Treatment Period |
| Any Cannabis Abstinence Across Four Treatment Strategies | Treatment period between week 1 and week 14 | Number of participants who achieved at least one week of abstinence |
| Weeks of Cannabis Abstinence Across Four Treatment Strategies | Treatment period between week 1 and week 14 | Mean weeks of continuous cannabis abstinence among those who achieved at least one week of abstinence |
Countries
United States
Participant flow
Recruitment details
Recruited from a community intensive outpatient program from December 2015 to October 2017.
Participants by arm
| Arm | Count |
|---|---|
| CM + WMT Intensive Outpatient Treatment + Contingency Management + Working Memory Training (IOP + CM + WMT) | 29 |
| CM + No WMT Intensive Outpatient Treatment + Contingency Management (IOP + CM) | 30 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 5 |
Baseline characteristics
| Characteristic | CM + WMT | Total | CM + No WMT |
|---|---|---|---|
| Age, Continuous | 16.0 years STANDARD_DEVIATION 1.5 | 16.35 years STANDARD_DEVIATION 1.7 | 16.7 years STANDARD_DEVIATION 2.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 54 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 45 Participants | 24 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 12 Participants | 4 Participants |
| Region of Enrollment United States | 29 participants | 59 participants | 30 participants |
| Sex: Female, Male Female | 8 Participants | 17 Participants | 9 Participants |
| Sex: Female, Male Male | 21 Participants | 42 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 29 | 0 / 30 |
| other Total, other adverse events | 8 / 29 | 7 / 30 |
| serious Total, serious adverse events | 0 / 29 | 0 / 30 |
Outcome results
Any Cannabis Abstinence
Number of participants with any cannabis abstinence during treatment
Time frame: Intervention weeks 1 to 14
Population: Participants who met Cannabis Use Disorder criteria, excluding those who met other drug use disorder criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CM + WMT | Any Cannabis Abstinence | 13 participants |
| CM + No WMT | Any Cannabis Abstinence | 18 participants |
Weeks of Continuous Cannabis Abstinence
Weeks of continuous abstinence during treatment
Time frame: 14 week treatment period
Population: Calculated only for those who achieved at least one week of abstinence during the treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CM + WMT | Weeks of Continuous Cannabis Abstinence | 7.15 Weeks of Continuous Abstinence | Standard Deviation 4.63 |
| CM + No WMT | Weeks of Continuous Cannabis Abstinence | 4.88 Weeks of Continuous Abstinence | Standard Deviation 4.35 |
Any Cannabis Abstinence Across Four Treatment Strategies
Number of participants who achieved at least one week of abstinence
Time frame: Treatment period between week 1 and week 14
Population: Ns in each strategy are the sum of \[1\] dropouts in the phase 1 condition, \[2\] responders in the phase 1 condition; and \[3\] nonresponders in the phase 1 condition who are assigned to the specified phase 2 condition. These ns for each strategy are: \[1\] 5+8+8=21; \[2\] 6+10+5=21; \[3\] 5+8+8=21; \[4\] 6+10+8=24.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CM + WMT | Any Cannabis Abstinence Across Four Treatment Strategies | 12 Participants |
| CM + No WMT | Any Cannabis Abstinence Across Four Treatment Strategies | 12 Participants |
| Strategy 3 | Any Cannabis Abstinence Across Four Treatment Strategies | 14 Participants |
| Strategy 4 | Any Cannabis Abstinence Across Four Treatment Strategies | 11 Participants |
Any Days of Cannabis Use
Number of participants with any days of cannabis use during treatment
Time frame: Intervention weeks 1 to 14
Population: Participants with Cannabis Use Disorder and with non-missing data on 25% or more of treatment days (excluding those with other drug use disorder)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CM + WMT | Any Days of Cannabis Use | 11 Participants |
| CM + No WMT | Any Days of Cannabis Use | 14 Participants |
Days of Cannabis Use
Percent of Days Used During the Treatment Period
Time frame: The intervention period between Week 1 and Week 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CM + WMT | Days of Cannabis Use | 32.5 percentage of days of cannabis use | Standard Deviation 31 |
| CM + No WMT | Days of Cannabis Use | 24.5 percentage of days of cannabis use | Standard Deviation 23.3 |
Weeks of Cannabis Abstinence Across Four Treatment Strategies
Mean weeks of continuous cannabis abstinence among those who achieved at least one week of abstinence
Time frame: Treatment period between week 1 and week 14
Population: Participants with at least one week of cannabis abstinence during treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CM + WMT | Weeks of Cannabis Abstinence Across Four Treatment Strategies | 6.17 weeks of continuous abstinence | Standard Deviation 4.73 |
| CM + No WMT | Weeks of Cannabis Abstinence Across Four Treatment Strategies | 7.42 weeks of continuous abstinence | Standard Deviation 4.74 |
| Strategy 3 | Weeks of Cannabis Abstinence Across Four Treatment Strategies | 5.29 weeks of continuous abstinence | Standard Deviation 4.43 |
| Strategy 4 | Weeks of Cannabis Abstinence Across Four Treatment Strategies | 7.82 weeks of continuous abstinence | Standard Deviation 4.75 |