Trial Outcomes & Findings for Gabapentin Treatment of Cannabis Dependence (NCT NCT00974376)
NCT ID: NCT00974376
Last Updated: 2017-06-06
Results Overview
Express Results Integrated Multi-Drug Screen Cups were used to obtain a semi-quantitative urine drug screen for delta-9-THC. Submitted UDS would yield a positive result when the concentration of THC-COOH in urine exceeded 50 ng/mL. Specimens were collected weekly. Two analytical approaches were used: one where any missed UDS test was assumed positive (i.e intent-to-treat (ITT)) and another where missed UDS were considered missing at random (MAR).
COMPLETED
PHASE2
150 participants
12 weeks
2017-06-06
Participant Flow
Participant milestones
| Measure |
Gabapentin 1200mg/Day
1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
|
Placebo
Matched placebo given in conjunction with standardized manual-guided behavioral counseling.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
|
Overall Study
COMPLETED
|
41
|
42
|
|
Overall Study
NOT COMPLETED
|
34
|
33
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gabapentin Treatment of Cannabis Dependence
Baseline characteristics by cohort
| Measure |
Gabapentin 1200mg/Day
n=75 Participants
1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
|
Placebo
n=75 Participants
Matched placebo given in conjunction with standardized manual-guided behavioral counseling.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.99 years
STANDARD_DEVIATION 10.68 • n=5 Participants
|
34.53 years
STANDARD_DEVIATION 11.99 • n=7 Participants
|
34.76 years
STANDARD_DEVIATION 11.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Two participants in the gabapentin group and one in the placebo group were lost to follow up after randomization and did not submit any UDS for testing while on study. Two participants in the placebo group withdrew from the study at the week 1 visit, and thus did not submit any UDS for testing while on study.
Express Results Integrated Multi-Drug Screen Cups were used to obtain a semi-quantitative urine drug screen for delta-9-THC. Submitted UDS would yield a positive result when the concentration of THC-COOH in urine exceeded 50 ng/mL. Specimens were collected weekly. Two analytical approaches were used: one where any missed UDS test was assumed positive (i.e intent-to-treat (ITT)) and another where missed UDS were considered missing at random (MAR).
Outcome measures
| Measure |
Gabapentin 1200mg/Day
n=75 Participants
1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
|
Placebo
n=75 Participants
Matched placebo given in conjunction with standardized manual-guided behavioral counseling.
|
|---|---|---|
|
Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period
% Negative UDS Observed
|
12.48 percentage of negative UDS
Standard Deviation 23.82
|
9.93 percentage of negative UDS
Standard Deviation 24.03
|
|
Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period
% Negative UDS ITT
|
11.22 percentage of negative UDS
Standard Deviation 21.77
|
8.00 percentage of negative UDS
Standard Deviation 19.83
|
Adverse Events
Gabapentin 1200mg/Day
Placebo
Serious adverse events
| Measure |
Gabapentin 1200mg/Day
n=75 participants at risk；n=150 participants at risk
1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
|
Placebo
n=75 participants at risk；n=150 participants at risk
Matched placebo given in conjunction with standardized manual-guided behavioral counseling.
|
|---|---|---|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/150
|
0.67%
1/150
|
|
Infections and infestations
Skin infection
|
0.00%
0/150
|
0.67%
1/150
|
Other adverse events
| Measure |
Gabapentin 1200mg/Day
n=75 participants at risk；n=150 participants at risk
1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
|
Placebo
n=75 participants at risk；n=150 participants at risk
Matched placebo given in conjunction with standardized manual-guided behavioral counseling.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
5/75
|
10.7%
8/75
|
|
Gastrointestinal disorders
Dyspepsia
|
1.3%
1/75
|
5.3%
4/75
|
|
Gastrointestinal disorders
Nausea
|
10.7%
8/75
|
10.7%
8/75
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
4/75
|
2.7%
2/75
|
|
General disorders
Fatigue
|
13.3%
10/75
|
4.0%
3/75
|
|
Infections and infestations
Nasopharyngitis
|
18.7%
14/75
|
25.3%
19/75
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/75
|
5.3%
4/75
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
3/75
|
5.3%
4/75
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.0%
9/75
|
5.3%
4/75
|
|
Nervous system disorders
Dizziness
|
8.0%
6/75
|
9.3%
7/75
|
|
Nervous system disorders
Headache
|
14.7%
11/75
|
20.0%
15/75
|
|
Nervous system disorders
Somnolence
|
9.3%
7/75
|
6.7%
5/75
|
|
Psychiatric disorders
Insomnia
|
5.3%
4/75
|
5.3%
4/75
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
1/75
|
5.3%
4/75
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place