Controlled Datasets | NIAAA

The National Epidemiologic Survey on Alcohol and Related Conditions-III (NESARC-III) was sponsored, designed and directed by the National Institute on Alcohol Abuse and Alcoholism (NIAAA). 

• Sponsor: The National Institute on Alcohol Abuse and Alcoholism
• NCT #: 01273220
• Study Type: Observational
• Number of Participants: 36,309
• Population: A cross-sectional, nationally representative sample of the civilian noninstitutionalized population of the United States aged 18 years or older.
• Study Details: NIAAA Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS-5) was used to collect on alcohol and drug use disorders, related risk factors and associated physical and mental disabilities; DNA was obtained through saliva samples. Fieldwork was conducted by Westat through a contract under the data collection authorization of Title 42 USC 285n.

How to Access Phenotypic NESARC-III Data

The NESARC III Study contains individual level data and is categorized as a controlled access data set. Only qualified research investigators who, along with their institutions, have certified their agreement with the expectations and terms of access detailed in the NESARC III Data Access Application and the NIAAA Data Use Agreement will be provided access. 

NESARC-III Resources:

A Multisite Trial of Combined Pharmacotherapies and Behavioral Interventions (COMBINE) for Alcohol Dependence Study is the largest pharmacotherapy trial conducted for Alcohol Use Disorder in the United States.  This clinical trial evaluated the efficacy of naltrexone and acamprosate, both alone and in combination, in the context of medical management with and without Combined Behavioral Intervention (CBI).  

• Sponsor: The National Institute on Alcohol Abuse and Alcoholism
• NCT #: 00006206
• Trial Type: Phase 3
• Treatment Arms:
  • CBI, Medical Management, Medication (Acamprosate, Naltrexone, Acamprosate + Naltrexone, or Placebo)
  • Medical Management and Medication (Acamprosate, Naltrexone, Acamprosate + Naltrexone, or Placebo)
  • CBI Only (No medication or placebo)
• Medications: 
  • Acamprosate 1000mg 3 times a day and matching placebo
  • Naltrexone 100mg once a day or matching placebo
• Number of clinical sites: 11
• Number of Participants: 1383
• Duration: 4 months; follow-ups 1-year post-intervention
• Population: Individuals with alcohol dependence; 31% women; 23% ethnic minorities
• Other Study Details: Double-blind, Combined Behavioral Intervention (intensive counseling by alcohol treatment specialists)

Top-line Results

All groups showed substantial reduction in drinking. Patients receiving naltrexone had a higher percent of days abstinent than those receiving medical management only, a significant naltrexone X behavioral intervention interaction (P=.009). Naltrexone also reduced the risk of a heavy drinking day (hazard ratio, 0.72, 97.5% CI, 0.53-0.98; P=.02n). Acamprosate showed no signification effect on drinking vs. placebo, either by itself or with any combination of naltrexone, CBI or both.

Publication

Anton RF, O'Malley SS, Ciraulo DA, Cisler RA, Couper D, Donovan DM, Gastfriend DR, Hosking JD, Johnson BA, LoCastro JS, Longabaugh R, Mason BJ, Mattson ME, Miller WR, Pettinati HM, Randall CL, Swift R, Weiss RD, Williams LD, Zweben A; COMBINE Study Research Group. 2006. Combined pharmacotherapies and behavioral interventions for alcohol dependence: the COMBINE study: a randomized controlled trial. JAMA 295(17):2003-17. PMID:16670409

How to Access Combine Study Data

The COMBINE Study contains individual level data and is categorized as a controlled access data set. Only qualified research investigators who, along with their institutions, have certified their agreement with the expectations and terms of access detailed in the COMBINE Data Access Application and the NIAAA Data Use Agreement will be provided access.

To apply for access, please send the following to NIAAA-DAC@mail.nih.gov 

• A completed COMBINE Data Access Application
• A completed NIAAA Data Use Agreement, signed by your Authorized Institutional Official and the Principal Investigator

NIAAA Protocol NCIG 001: A Multisite Double-Blind, Placebo-Controlled Trial of Quetiapine Fumarate XR in Very Heavy-Drinking Alcohol-Dependent Patients

Study Details

This double-blind, randomized placebo-controlled trial evaluated the efficacy and safety of quetiapine, for the treatment of alcohol use disorder (AUD).  

• Sponsor: The National Institute on Alcohol Abuse and Alcoholism’s Clinical Investigations Group (NCIG) 
• NCT #: 00498628 
• Phase:  Phase 2 
• Treatment Arms: Quetiapine 400mg daily and matching placebo 
• Number of clinical sites: 5  
• Number of Participants: 224 
• Duration: 3 months; efficacy weeks 3-11 
• Population: Adults with Alcohol Use Disorder; 20% women; 18% ethnic minorities 
• Other Study Details: Double-blind

Top-line Results

No differences between the quetiapine and placebo groups were detected in the primary outcome, percentage heavy-drinking days, or other drinking outcomes. Quetiapine significantly reduced depressive symptoms and improved sleep but had no effect on other nondrinking outcomes.  Quetiapine was generally well tolerated. Statistically significant adverse events that were more common with quetiapine versus placebo include dizziness, dry mouth, dyspepsia, increased appetite, sedation, and somnolence. 

The data set was prepared by NIAAA and the VA Maryland Health Care System (the Coordinating Center) and was reviewed by CSR Incorporated.

Publication

Litten RZ, Fertig JB, Falk DE, Ryan ML, Mattson ME, Collins JF, Murtaugh C, Ciraulo D, Green AI, Johnson B, Pettinati H, Swift R, Afshar M, Brunette MF, Tiouririne NA, Kampman K, Stout R, and the NCIG 001 Study Group (2012). A double-blind, placebo-controlled trial to assess the efficacy of quetiapine fumarate XR in very heavy-drinking alcohol-dependent patients. Alcohol Clin Exp Res 36(3):406-16.  PMID: 21950727

How to Access Quetiapine Study Data

The Quetiapine Study contains individual level data and is categorized as a controlled access data set. Only qualified research investigators who, along with their institutions, have certified their agreement with the expectations and terms of access detailed in the Quetiapine Data Access Application and the NIAAA Data Use Agreement will be provided access.  

To apply for access, please send the following to NIAAA-DAC@mail.nih.gov 

• A completed NCIG 001 – Quetiapine Data Access Application 
• A completed NIAAA Data Use Agreement, signed by your Authorized Institutional Official and the Principal Investigator

NIAAA Protocol NCIG 002: A Multisite Double-Blind, Placebo-Controlled Trial of Levetiracetam Extended-Release in Very Heavy-Drinking Alcohol-Dependent Patients

Study Details

This multisite clinical trial evaluated the efficacy and safety of levetiracetam XR, for the treatment of alcohol use disorder (AUD). 

• Sponsor: The National Institute on Alcohol Abuse and Alcoholism’s Clinical Investigations Group (NCIG)
• NCT #: 00970814
• Phase: Phase 2
• Treatment Arms: Levetiracetam XR 2000mg daily and matching placebo
• Number of clinical sites: 5
• Number of Participants: 130
• Duration: 4 months; efficacy weeks 5-14
• Population: Adults with Alcohol Use Disorder; 34% women; 31% ethnic minorities
• Other Study Details: Double-blind, Brief Behavioral Compliance Enhancement Treatment (BBCET) intervention.

Top-line Results

No significant differences were detected between the levetiracetam XR and placebo groups in either the primary outcomes (percent heavy drinking days and percent subjects with no heavy drinking days) or in other secondary drinking outcomes. Treatment groups did not differ on a number of nondrinking outcomes, including depression, anxiety, mood, and quality of life. The only difference observed was in alcohol-related consequences. The levetiracetam XR treatment group showed significantly fewer consequences than did the placebo group during the maintenance period (p=0.02). Levetiracetam XR was well-tolerated, with fatigue being the only significantly elevated adverse event, compared with placebo (53% vs. 24%, respectively; p=0.001).

The data set was prepared by NIAAA and FastTrack Drugs and Biologics, (the Coordinating Center) and was reviewed by CSR Incorporated. 

Publication

Fertig JB, Ryan ML, Falk DE, Litten RZ, Mattson ME, Ransom J, Rickman WJ, Scott C, Ciraulo D, Green AI, Tiouririne NA, Johnson B, Pettinati H, Strain EC, Devine E, Brunette MF, Kampman K, A Tompkins D, Stout R; NCIG 002 Study Group. 2012. A double-blind, placebo-controlled trial assessing the efficacy of levetiracetam extended-release in very heavy drinking alcohol-dependent patients. Alcohol Clin Exp Res 36(8):1421-30.  PMID: 22324516 

How to Access Levetiracetam Study Data

The Levetiracetam XR Study contains individual level data and is categorized as a controlled access data set. Only qualified research investigators who, along with their institutions, have certified their agreement with the expectations and terms of access detailed in the Levetiracetam Data Access Application and the NIAAA Data Use Agreement will be provided access. 

To apply for access, please send the following to NIAAA-DAC@mail.nih.gov 

• A completed NCIG 002 – Levetiracetam Data Access Application
• A completed NIAAA Data Use Agreement, signed by your Authorized Institutional Official and the Principal Investigator

NIAAA Protocol NCIG 003: A Phase 2, Double-Blind, Placebo Controlled Trial to Assess the Efficacy of Varenicline Tartrate for Alcohol Dependence

Study Details

This double-blind, randomized placebo-controlled trial evaluated the efficacy and safety of varenicline tartrate for the treatment of alcohol use disorder (AUD). 

• Sponsor: The National Institute on Alcohol Abuse and Alcoholism’s Clinical Investigations Group (NCIG)
• NCT #: 01146613
• Phase: Phase 2
• Treatment Arms: Varenicline tartrate 1mg twice a day and matching placebo
• Number of clinical sites: 5
• Number of Participants: 200
• Duration: 12 weeks
• Population: Adults diagnosed with AUD in the past year; 29% women; 35% ethnic minorities
• Other Study Details: Double-blind, Take Control (computerized behavioral intervention)

Top-line Results

The varenicline group had significantly lower weekly percent heavy drinking days (primary outcome) (adjusted mean difference = 10.4), drinks per day, drinks per drinking day, percent very heavy drinking days, alcohol craving, and cigarettes smoker per day, compared with the placebo group (P < 0.05). Varenicline was well-tolerated; adverse events were expected and mild. Three adverse events occurred at statistically greater rates in the varenicline group that the placebo group: nausea (37.1% vs 17.8%, respectively); abnormal dreams (27.8% vs 11.9%, respectively); and constipation (9.3% vs 2.0%, respectively).

The data set was prepared by NIAAA and FastTrack Drugs and Biologics, (the trials Coordinating Center) and was reviewed by CSR Incorporated. 

Publication

Litten RZ, Ryan ML, Fertig JB, Falk DE, Johnson B, Dunn KE, Green AI, Pettinati HM, Ciraulo DA, Sarid-Segal O, Kampman K, Brunette MF, Strain EC, Tiouririne NA, Ransom J, Scott C, Stout R; NCIG (National Institute on Alcohol Abuse and Alcoholism Clinical Investigations Group) Study Group. 2013. A double-blind, placebo-controlled trial assessing the efficacy of varenicline tartrate for alcohol dependence. J Addict Med 7(4):277-86.  PMID: 23728065

How to Access Varenicline Study Data

Because the Varenicline Study contains individual level data, it is categorized as a controlled access data set. Access will only be provided to qualified research investigators who, along with their institutions, have certified their agreement with the expectations and terms of access detailed in the Varenicline Data Access Application and the NIAAA Data Use Agreement.

To apply for access, please send the following to NIAAA-DAC@mail.nih.gov 

• A completed NCIG 003 - Varenicline Data Access Application
• A completed NIAAA Data Use Agreement, signed by your Authorized Institutional Official and the Principal Investigator

NIAAA Protocol NCIG 006: A Randomized, Double Blind, Placebo-Controlled Trial of the Safety and Efficacy of HORIZANT® (Gabapentin Enacarbil) Extended-Release Tablets for the Treatment of Alcohol Use Disorder

Study Details

This large, multisite clinical trial evaluated the efficacy and safety of gabapentin enacarbil extended-release (GE-XR) (HORIZANT®), a gabapentin prodrug formulation for the treatment of alcohol use disorder (AUD).

• Sponsor: The National Institute on Alcohol Abuse and Alcoholism’s Clinical Investigations Group (NCIG)
• NCT #: 02252536
• Phase: Phase 2
• Treatment Arms: Horizant® (gabapentin enacarbil) 600mg twice a day and matching placebo
• Number of Clinical Sites: 10
• Number of Participants: 346
• Duration: 6 months; efficacy last 4 weeks
• Population: Minimum of mild AUD; 34% women; 31% ethnic minorities
• Other Study Details: Double-blind, Take Control (computerized behavioral intervention)

Top-line Results

The Horizant® and placebo groups did not differ significantly on the primary outcome measure, percentage of subjects with no heavy drinking days (28.3 vs. 21.5, respectively, p = 0.157) or on any secondary measures of drinking, craving, alcohol-related consequences, mood, sleep, or smoking. Common side-effects were fatigue, dizziness, and somnolence.

The data set was prepared by NIAAA and FastTrack Drugs and Biologics, (the Coordinating Center) and was reviewed by CSR Incorporated.

Publication

Falk DE, Ryan ML, Fertig JB, Devine EG, Cruz R, Brown ES, Burns H, Salloum IM, Newport DJ, Mendelson J, Galloway G, Kampman K, Brooks C, Green AI, Brunette MF, Rosenthal RN, Dunn KE, Strain EC, Ray L, Shoptaw S, Ait-Daoud Tiouririne N, Gunderson EW, Ransom J, Scott C, Leggio L, Caras S, Mason BJ, Litten RZ; National Institute on Alcohol Abuse and Alcoholism Clinical Investigations Group (NCIG) Study Group. 2019. Gabapentin enacarbil extended-release for alcohol use disorder: a randomized, double-blind, placebo-controlled, multisite trial assessing efficacy and safety. Alcohol Clin Exp Res, 43(1):158-169. PMID: 30403402

How to Access Horizant Study Data

HORIZANT® (Gabapentin Enacarbil) Extended-Release Study contains individual level data and is categorized as a controlled access data set. Only qualified research investigators who, along with their institutions, have certified their agreement with the expectations and terms of access detailed in the Gabapentin Enacarbil Data Access Application and the NIAAA Data Use Agreement will be provided access.

To apply for access, please send the following to NIAAA-DAC@mail.nih.gov 

• A completed NCIG 006 - Gabapentin Enacarbil Data Access Application
• A completed NIAAA Data Use Agreement, signed by your Authorized Institutional Official and the Principal Investigator