Behavioral Treatment of Adolescent Marijuana Use
Phase: NA
Conditions: Substance Use Disorders
Sponsor: Dartmouth-Hitchcock Medical Center

NCT02063984   Unique Protocol ID: DA015186-DartmouthSpectrum    
Secondary IDs: R01DA015186-12A1 
Brief Title: Behavioral Treatment of Adolescent Substance Use (SMART) 
 
2/17/15 
 
 
 

 
Design, procedures, materials and methods:   
We will recruit adolescent male and females, who enroll in substance use treatment at 
Mountain Manor Treatment Center Treatment is 26 weeks in duration total, and half the 
participants will be randomly assigned to Treatment A and receive CM/WMT and the other half 
of participants will be randomly assigned to Treatment B and receive CM only.   Weeks 1-14 
involve once weekly sessions with a therapist. The individual sessions will involve a review of 
substance use, the incentive program, spending ideas, and clarify any questions. The individual 
sessions will last approximately 30 minutes. Weeks 1-14 also involve once-weekly drug testing.  
In Treatment A, WMT will be delivered, usually starting in week 2 at Mountain Manor. Weeks 
15-26 involve drug testing only. Post-treatment assessment will occur at the end of treatment. 
There will be three follow up assessments: 14 weeks, 6 months, and 12 months after intake.  
The final study visit will be the 12 month follow up assessment.  
 
Participants will be randomly assigned to one of two first-line interventions (CM or CM with 
active WMT). Then treatment response will be assessed at week 4, and non-responders will be 
randomly assigned to either continue with assigned intervention or to an intensive contingency 
management (ICM) intervention.  
 
Clinical Site and Participant Recruitment: Participants will present for treatment at Mountain 
Manor Treatment Center in Baltimore, Maryland.  Counselors are Master’s level licensed 
Psychology Associates.   
 
Youth who present for substance use treatment at Mountain Manor will be screened for 
eligibility and provided the opportunity to participate in the study. We expect to enroll at least 
5 youth per month based on the census at Mountain Manor and their history of recruiting 
youth in their programs into clinical research protocols. 
 
Treatment Components Delivered to all Participants  
 
Clinic-delivered CM.  All youth will receive our standard escalating CM incentive program.  
In weeks 1-2, participants receive $10 incentives for each urine specimen provided as 
scheduled, regardless of results to facilitate initial compliance with providing specimens. During 
weeks 3–14, the program targets abstinence from marijuana and other substances by awarding 
incentives for documented abstinence. Abstinence is defined as abstinence from all substances 
determined by: 1) urine and breath alcohol tests indicate no use, and 2) participant reports no 
alcohol or drug use since the last test. The escalating schedule has a maximum value of $570 
(complete abstinence). Participants will receive a reloadable prepaid Mastercard (CTpayer, 
Inc.), and staff will remotely load earned incentives onto the card after each session. The card 
does not allow teens to withdraw cash. During Weeks 15–26, participants will attend weekly 
substance testing, and begin a renewed incentive schedule that starts with a $10 incentive and 
increases by $2 per week.   
                                                                              

Working Memory Training.  Usually beginning in Week 2, youth assigned to Treatment A will 
start WMT and will complete up to 5 WMT sessions per week at the clinic (30-45 min), with the 
goal of completing at least 25 sessions; this replicates or exceeds the number of WMT sessions 
from previous studies with adults and adolescents. Youth will be trained using Cogmed-RM 
(Pearson,Inc), which is a commercially available, program used successfully to train WM in 
youth samples (e.g., normal, ADHD, low birth weight history).(Gibson et al., 2011; Holmes et al., 
2010; Klingberg et al., 2005; Klingberg et al., 2002; Lohaugen et al., 2011) The PI, Co-I and the 
RA have obtained administrative and coach training needed to ensure WMT fidelity.  Mountain 
Manor is currently using WMT in a research protocol with the same population targeted for this 
study. 
 
Each session will include 15 trials from each of 8 of a possible 12 different WM 
exercises. The program includes a series of verbal and visuospatial WM tasks with appropriately 
designed graphics and tasks for this age group. Each task involves the temporary storage and 
manipulation of visuospatial or verbal information, or both. In the adaptive version, an 
algorithm based on performance automatically adjusts task difficulty and promotes training at a 
participant’s individual WM capacity. An algorithm also rotates exercises so that equal numbers 
of trials across each of the 12 exercises are completed. The program has built-in motivational 
features designed to promote effort and interest, including positive feedback, displays of best 
scores and earnings on an ‘energy bar’ that activate access to a robo-racing game.  
We will use additional incentives to reinforce effort and improvement, a technique employed in 
many rehabilitation programs. Youth will get $10 on their reloadable card each time they 
complete a session. Average scores across each session that are equal to or greater than prior 
sessions earn a second $5. Youth will also earn a $20 bonus for either completing 3 or more 
sessions in a week or completing 1 or more sessions than the week before (minimum of 2 
sessions). Participants who meet these criteria throughout the study would earn $470.  
 
Intensified Contingency Management (ICM): After 4 weeks of treatment, response will be 
assessed.  Early responders (those abstinent in Week 4) will continue in their assigned 
intervention. Non-responders (still using substances in Week 4) will be randomly assigned to 
either continue with the assigned intervention for weeks 5–14 or to begin the ICM intervention.  
Those assigned to ICM will discontinue their CM incentive program, and initiate a new 11-week 
incentive program of higher magnitude during Weeks 5-14. ICM differs from CM in that the 
magnitude of the incentives will increase by approximately three times the relative magnitude 
of the initial incentive system. This is consistent with a prior adult study, which yielded a 50% 
positive response rate with this level of increase.(Silverman et al., 1999) ICM during this period 
will have maximum earnings of $1225 for continuous abstinence across weeks 5-14.  
Procedures: 
 
Initial evaluation, informed consent/assent, treatment assignment.  The youth must attend 
the intake evaluation, and sign consent/assent forms covering the intake process and trial 
participation. Participants will be randomly assigned to one of two first-line interventions (CM 
or CM with active WMT).  
 

Regarding the WMT assignment: Participants will be told, “you will be assigned randomly to 
either receive 25 sessions of WMT or not.”  
 
Regarding the potential reassignment to ICM, participants will be told: “at week 4, we will 
assess your treatment response. If you are doing well (not using substances), you will continue 
with your current treatment plan. If you are still using substances, you will be randomly 
assigned to either remain in your current treatment or to a treatment with a revised incentive 
plan. Details of the revised plan will be explained after reassignment.”   
 
Random assignment to the first line intervention (CM or CM/WMT) will occur immediately prior 
to session 1. Randomizations will be made using minimum-likelihood allocation as done 
successfully in prior trials to ensure groups are balanced for variables that may correlate highly 
with outcome assessments.  The first randomization will be balanced on 6 measures: 1) 
abstinence prior to treatment initiation, 2) clinically significant conduct problems at intake, 3) 
age > 16, 4) gender, 5) race (white vs. other), 6) receiving treatment for opioid use disorder. The 
second randomization of non-responders will occur in Week 4 and will be balanced on variables 
2 through 5.  
 
Substance monitoring. Participants provide specimens once-weekly during weeks 1–26. Staff 
are trained and receive ongoing supervision related to handling questions about urine test 
results. We will use rapid testing devices that provide qualitative results because of ease of use, 
low cost, and likely use in dissemination efforts. We will protect from invalid results by using 
test strips for creatinine levels and four indicators of adulteration. Participants with invalid 
specimens will be asked to provide another specimen within 4–24 hrs. The criteria for cannabis 
abstinence will be determined by a negative result on our cannabis rapid testing devices; the 
cutoff on these devices is 50ng/ml.  This is the standard THC level set for establishing 
abstinence in clinical studies, which reflects the clinical standard for using urine results with 
abstinence-based contingency management intervention.  We, and others, have used these 
procedures effectively in multiple clinical trials.   
 
Staff contact participants who do not attend the clinic at scheduled times, and when necessary, 
offer to collect specimens away from the clinic. Outreach collection will occur only with 
permission from the participants. In prior trials, <3% of specimens were collected away from 
the clinic. Failure to submit a specimen without making alternative arrangements is treated as 
testing positive for CM implementation. 
 
Statistical Methods. 
The a priori, primary hypothesis of the study was that youth receiving CM _ WMT would have 
better substance use outcomes than those receiving CM. When comparing the two Phase 1 
intervention conditions, such analyses are no different from those in a “standard” randomized 
controlled trial. Zero-inflated negative binomial (ZINB) models compared cannabis use (percent 
days used and WCA) between conditions during the intervention (Atkins, Baldwin, Zheng, 
Gallop, & Neighbors, 2013). ZINB models were used because both outcomes were zero inflated 
(_22% of youth had 0% of days used cannabis and 47% had zero WCA) and somewhat 

overdispersed (estimated dispersion parameters: WCA _ .69, 95% CI [.25, 1.91]; percent days 
used _ .67, 95% CI [.36, 1.25]).  
 
Exploratory analyses compared the four treatment strategies embedded in the trial (see Table 
1). Analysis of the treatment strategies requires additional statistical considerations (e.g., 
weighting and the use of robust [sandwich] standard errors), which are described in detail in 
Nahum-Shani et al. (2012).  
 
In addition, to compare the four strategies simultaneously, duplicate observations for each 
responder and for each participant who dropped out before the Phase 2 randomization were 
added to the data set and assigned to multiple strategies based on starting condition and 
response. For example, responders assigned to stay in STANDARD CM are included in Strategy 1 
(all start in STANDARD CM, all stay in STANDARD CM) and Strategy 3 (all start in STANDARD CM, 
responders stay in STANDARD CM, and nonresponders switch to ENHANCED CM). In these 
analyses, the “lowest” level of treatment (start in STANDARD CM and stay in STANDARD) was 
the comparison condition. TLFB models adjusted for baseline TLFB values. A total of 37 of 59 
(63%) participants provided TLFB data on at least 25% of the days during treatment. The 
percentage of nonmissing TLFB data did not differ significantly between treatment arms, age, 
race, intake use, tobacco use status, or CUD severity (data not shown).  
 
There are no missing WCA data because missing specimens are considered not abstinent. A 
sensitivity analysis was performed using the number of negative samples, which treated missing 
specimens as missing. The same pattern of results was observed. All analyses were performed 
using SAS Version 9.4. All tests were conducted using a two-sided alpha threshold of .05.