Alcohol Use Disorder
Conditions
Keywords
alcohol, youth, adolescent, pharmacotherapy, medication, N-acetylcysteine
Brief summary
This is a 8-week randomized, placebo-controlled trial testing the effects of N-acetylcysteine (NAC), on a platform of weekly evidence-based brief alcohol intervention for 120 adolescents with alcohol use disorder (AUD). The primary efficacy endpoint is reduction in alcohol use (total standard drinks), compared between NAC and placebo groups.
Detailed description
Adolescence is a critical developmental stage involving marked elevation in alcohol initiation, progression to AUD, and development of significant, lasting adverse outcomes from use. Effective treatments must be developed for AUD in this especially vulnerable age range. The identification of a well-tolerated, effective pharmacological treatment would represent a significant advance and could yield tremendous public health impact. The proposed trial will provide critical data to evaluate NAC as a highly promising pharmacotherapy for adolescent AUD, and regardless of NAC versus placebo outcomes will provide key methodological guidance for future randomized controlled trials of pharmacotherapies for adolescent AUD. Randomized participants will be provided and instructed to take their assigned medication at 1200 mg twice daily, in approximately twelve-hour intervals.
Interventions
DRUGN-acetylcysteine
N-acetylcysteine 1200 mg twice daily for 8 weeks (administered orally)
DRUGPlacebo oral capsule
Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally)
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind placebo-controlled pharmacotherapy trial
Intervention model description
1:1 parallel group allocation randomized placebo controlled trial
Eligibility
Sex/Gender
ALL
Age
13 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is 13-25 2. Must be able to understand the study and provide written informed consent (for participants under 18 years old, a parent/legal guardian must be able to provide consent and the participant must be able to provide assent). 3. Current moderate to heavy drinker by established adolescent criteria 4. Meet criteria for alcohol use disorder 5. Females must agree to use appropriate birth control methods during study participation: oral contraceptives, contraceptive patch, barrier (diaphragm or condom), levonorgestrel implant, medroxyprogesterone acetate, complete abstinence from sexual intercourse, or hormonal contraceptive vaginal ring
Exclusion criteria
1. Score \>10 on the Clinical Institute Withdrawal Assessment for Alcohol 2. Allergy or intolerance to N-acetylcysteine 3. Females who are pregnant, contemplating pregnancy or lactating over the next 6 months 4. Current use of N-acetylcysteine or any supplement containing N-acetylcysteine (must agree not to take any such supplement throughout study participation) 5. Current enrollment in treatment for alcohol use disorder or expectation of other treatment during protocol participation 6. Any other medical or psychiatric condition or other significant concern that in the Investigator's opinion would impact participant safety or compliance with study instructions, or potentially cofound the interpretation of findings
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Use During the Final 4 Weeks of Treatment (Weeks 5 - 8) | Final 4 weeks of treatment | Alcohol use (total standard drinks) during the final four weeks of treatment (Weeks 5-8), compared between NAC and placebo groups. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| N-acetylcysteine N-acetylcysteine 1200 mg twice daily for 8 weeks; administered orally
N-acetylcysteine: N-acetylcysteine 1200 mg twice daily for 8 weeks (administered orally) | 65 |
| Placebo Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 8 weeks; administered orally
Placebo oral capsule: Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally) | 61 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 17 |
| Overall Study | Withdrawal by Subject | 6 | 6 |
Baseline characteristics
| Characteristic | N-acetylcysteine | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 21.1 years STANDARD_DEVIATION 2.3 | 21.0 years STANDARD_DEVIATION 2.4 | 20.9 years STANDARD_DEVIATION 2.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 9 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants | 117 Participants | 55 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 | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 8 Participants | 5 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 58 Participants | 111 Participants | 53 Participants |
| Region of Enrollment United States | 65 participants | 126 participants | 61 participants |
| Sex: Female, Male Female | 41 Participants | 78 Participants | 37 Participants |
| Sex: Female, Male Male | 24 Participants | 48 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 61 |
| other Total, other adverse events | 48 / 65 | 41 / 61 |
| serious Total, serious adverse events | 0 / 65 | 0 / 61 |
Outcome results
Primary
Alcohol Use During the Final 4 Weeks of Treatment (Weeks 5 - 8)
Alcohol use (total standard drinks) during the final four weeks of treatment (Weeks 5-8), compared between NAC and placebo groups.
Time frame: Final 4 weeks of treatment
Population: Randomized participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| N-acetylcysteine | Alcohol Use During the Final 4 Weeks of Treatment (Weeks 5 - 8) | 37.9 Standard drinks | Standard Deviation 28.3 |
| Placebo | Alcohol Use During the Final 4 Weeks of Treatment (Weeks 5 - 8) | 42.6 Standard drinks | Standard Deviation 43.1 |