Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Cognitive and Cerebral Blood Flow Effects of 2-week Caffeine Abstinence or Maintenance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Crystal Haskell, Northumbria University
ClinicalTrials.gov Identifier:
NCT01376882
First received: June 16, 2011
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to determine the effects of 2 weeks caffeine abstinence as compared to 2 weeks caffeine maintenance (300mg per day)on cognition and mood. Cerebral blood flow effects will also be assessed in a subset of participants. The role of caffeine abstinence/maintenance in the acute effects of caffeine will also be explored.


Condition Intervention
Cognitive Function
Mood
Cerebral Haemodynamics
Caffeine Withdrawal
Dietary Supplement: Placebo
Dietary Supplement: Caffeine and Placebo
Dietary Supplement: Placebo and Caffeine
Dietary Supplement: Caffeine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Behavioural and Cerebral Haemodynamic Effects of Caffeine Withdrawal and Caffeine Administration Following 2-week Maintenance or Abstinence

Resource links provided by NLM:


Further study details as provided by Northumbria University:

Primary Outcome Measures:
  • Cognitive performance [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Performance is assessed using COMPASS (Computerised Mental Performance Assessment System), which presents a battery of standard cognitive tasks assessing aspects of attention and memory.


Secondary Outcome Measures:
  • Mood [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Mood will be evaluated using Visual Analogue Scales administered using COMPASS.

  • Cerebral haemodynamic [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Cerebral blood flow will be measured in a subset of participants using Near Infrared Spectroscopy (NIRS).

  • Sleep [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Quality of sleep will be measured using the Pitsburgh Sleep Quality Index (PSQI).

  • Caffeine withdrawal [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Symptoms of caffeine withdrawal will be measured using a Subjective and Somatic State Questionnaire.


Enrollment: 110
Study Start Date: March 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acute withdrawal
Chronic intervention 100 mg caffeine capsules 3 times per day for 14 days. Acute intervention of placebo capsule on day 15.
Dietary Supplement: Caffeine and Placebo
100 mg Caffeine capsules 3 times per day for 14 days and 1 size 0 capsule of inert placebo containing silica powder CAB-O-SIL-M-5Pharma (Pharmaceutical grade)CABOT GmbH on day 15.
Experimental: Acute caffeine-independent of withdrawal
Chronic intervention of placebo capsules 3 times per day for 14 days. Acute intervention of 100 mg caffeine capsule on day 15.
Dietary Supplement: Placebo and Caffeine
Inert placebo capsules containing silica powder CAB-O-SIL-M-5Pharma (Pharmaceutical grade)CABOT GmbH, 1 Size 0 capsule 3 times a day for 14 days and a 100mg caffeine capsule on day 15.
Experimental: Chronic abstinence
Chronic intervention of placebo capsules 3 times per day for 14 days. Acute intervention of placebo capsule on day 15.
Dietary Supplement: Placebo
Inert placebo containing silica powder CAB-O-SIL-M-5Pharma (Pharmaceutical grade)CABOT GmbH. 1 Size 0 capsule 3 times a day for 14 days and 1 size 0 capsule on day 15.
Experimental: Acute caffeine-in state of withdrawal
Chronic intervention of 100 mg caffeine capsule 3 times per day for 14 days. Acute intervention of 100 mg caffeine capsule on day 15.
Dietary Supplement: Caffeine
Capsule containing 100 mg caffeine, one 3 times a day for 14 days and then one capsule on day 15.

Detailed Description:

The current randomised, placebo-controlled, double-blind, parallel groups study aims to explore the behavioural effects of 2-weeks caffeine abstinence as well as establishing the role of abstinence in the effects of caffeine administration by administering caffeine or placebo to those in a state of chronic and acute abstinence. This research also aims to explore, in a subset of participants, the cerebral blood flow effects of caffeine abstinence and caffeine administration using Near Infrared Spectroscopy (NIRS). Cerebral blood flow will be measured both at rest and during performance of cognitive tasks.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male/Female
  • 18 - 40 years
  • Healthy
  • Consume ≥ 150 mg caffeine daily
  • No herbal supplements/prescription medications (excl. contraceptive pill)
  • Non smoker
  • Native English speaker

Exclusion Criteria:

  • Diagnosis of any significant medical condition or disorder
  • Any known allergy or hypersensitivity to food.
  • BMI >29.9 or <18.5
  • Blood pressure >139/89
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01376882

Locations
United Kingdom
Brain, Performance and Nutrition Research Centre, Northumbria University
Newcastle-upon-Tyne, Tyne and Wear, United Kingdom, NE1 8ST
Sponsors and Collaborators
Northumbria University
Investigators
Principal Investigator: Crystal Haskell, PhD Northumbria University
  More Information

Additional Information:
No publications provided

Responsible Party: Crystal Haskell, Dr, Northumbria University
ClinicalTrials.gov Identifier: NCT01376882     History of Changes
Other Study ID Numbers: 24G4
Study First Received: June 16, 2011
Last Updated: March 28, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Northumbria University:
Caffeine
Withdrawal
Cognitive function
Mood
Cerebral haemodynamics

Additional relevant MeSH terms:
Caffeine
Central Nervous System Agents
Central Nervous System Stimulants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Purinergic Agents
Purinergic Antagonists
Purinergic P1 Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014