Substance Use Disorders
Conditions
Brief summary
This research is being done to learn if computer tasks that challenge the brain (cognitively stimulating tasks) can improve memory and other types of thinking. The study will compare the effects of different versions of the computer tasks. It also will compare the task performance of different groups of people.
Interventions
BEHAVIORALComputerized cognitively stimulating activities
The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
Sponsors
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* age 18-55 * in methadone maintenance or healthy volunteers * healthy
Exclusion criteria
* Axis I disorder (except substance abuse and dependence in methadone maintenance patients) * severe cognitive impairment * serious untreated medical condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Working Memory | baseline, 7 weeks | Change in maximum number of digits correctly recalled in Digit Span Backwards task, from baseline to 7 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Episodic Memory | baseline, 7 weeks |
| Trail-making | baseline, 7 weeks |
| go/No-go | baseline, 7 weeks |
| Delay Discounting | baseline, 7 weeks |
| Digit Symbol Substitution Test | baseline, 7 weeks |
| Addiction Severity Index | baseline, 7 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cognitively Stimulating Activities Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks. | 28 |
| Cognitively Stimulating Activities: Other Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks. | 28 |
| Total | 56 |
Baseline characteristics
| Characteristic | Cognitively Stimulating Activities | Cognitively Stimulating Activities: Other | Total |
|---|---|---|---|
| Age, Continuous | 43.3 years STANDARD_DEVIATION 8.8 | 43.5 years STANDARD_DEVIATION 7.1 | 43.4 years STANDARD_DEVIATION 7.9 |
| Region of Enrollment United States | 28 participants | 28 participants | 56 participants |
| Sex: Female, Male Female | 14 Participants | 16 Participants | 30 Participants |
| Sex: Female, Male Male | 14 Participants | 12 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 37 | 0 / 36 |
| serious Total, serious adverse events | 0 / 37 | 0 / 36 |
Outcome results
Primary
Working Memory
Change in maximum number of digits correctly recalled in Digit Span Backwards task, from baseline to 7 weeks
Time frame: baseline, 7 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adaptive Cognitively Stimulating Activities | Working Memory | 0.86 digits recalled | Standard Deviation 1.21 |
| Non-adaptive Cognitively Stimulating Activities | Working Memory | 0.04 digits recalled | Standard Deviation 0.92 |
Secondary
Addiction Severity Index
Time frame: baseline, 7 weeks
Secondary
Delay Discounting
Time frame: baseline, 7 weeks
Secondary
Digit Symbol Substitution Test
Time frame: baseline, 7 weeks
Secondary
Episodic Memory
Time frame: baseline, 7 weeks
Secondary
go/No-go
Time frame: baseline, 7 weeks
Secondary
Trail-making
Time frame: baseline, 7 weeks