Table 2.
Treatment Retention and Outcome Variables | Galantamine | Placebo | Total Sample | Statistics: 3 group (8mg, 16mg, placebo) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
8mg | 16mg | ||||||||||||||
Mean | SD | n | Mean | SD | n | Mean | SD | n | Mean | SD | n | F | df | p | |
A. Treatment/Protocol Adherence | |||||||||||||||
Days in Treatment Protocol (week 1 to 12)a | 60.1 | 34.1 | 31 | 45.9 | 37.3 | 30 | 58.1 | 34.2 | 32 | 54.8 | 35.4 | 93 | 1.46 | 2,90 | 0.24 |
Days in Treatment Protocol (week 4 to 12)b | 38.2 | 23.5 | 31 | 27.6 | 26.1 | 30 | 36.3 | 24.0 | 32 | 34.2 | 24.7 | 93 | 1.62 | 2,90 | 0.20 |
Days of Data Reported on Substance Use Calendar (TLFB) (week 4 to 12)b | 47.2 | 15.7 | 25 | 34.9 | 25.1 | 21 | 41.9 | 21.1 | 26 | 41.7 | 21 | 72 | 2 | 2,69 | 0.14 |
% Urines Submitted (of Expected) (week 4 to 12)b | 85.8 | 21.4 | 24 | 77.9 | 22 | 17 | 84.4 | 21.6 | 24 | 83.2 | 21.5 | 65 | 0.71 | 2,62 | 0.50 |
% Clinic/Medication Dispensing Visits Attended (of Expected) (week 4 to 12)b, c | 71.9 | 44.3 | 30 | 48.2 | 48 | 29 | 68.8 | 43.2 | 31 | 63.2 | 45.9 | 90 | 2.38 | 2,87 | 0.10 |
B. Cocaine Use Outcomes | |||||||||||||||
% Negative Cocaine Urines (week 4 to 12)b | 31.0 | 36.8 | 23 | 22.9 | 31.1 | 17 | 28.1 | 36.6 | 24 | 27.8 | 34.9 | 64 | 0.25 | 2,62 | 0.78 |
% Days Cocaine Abstinence (self-report) (week 4 to 12)b | 27.9 | 25.5 | 22 | 29 | 21.3 | 15 | 29.3 | 27.7 | 24 | 28.7 | 25.1 | 61 | 0.02 | 2,59 | 0.98 |
Longest Consecutive Days Cocaine Abstinence (self-report) (week 4 to 12)b | 13.9 | 14.7 | 25 | 8.2 | 10.1 | 21 | 13.4 | 15.2 | 26 | 12.1 | 13.8 | 72 | 1.16 | 2,69 | 0.32 |
Week 1 to 12 encapsulates the full galantamine treatment period, including titration. Week 0, where all groups received placebo, is not included.
Week 4 to 12 is restricted to the galantamine treatment period following titration, therefore the group randomized to 16mg galantamine were receiving 16mg galantamine/day during this time.
The pills (galantamine or placebo) were dispensed at each clinic/medication dispensing visit: participants were observed (by a member of the research team) ingesting that day’s pill(s), then were given take-home pills to cover them until the next scheduled clinic visit. CM payments were based on adherence with this visit protocol.