A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Completed
• CT.gov ID: NCT01005810
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 116
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 5.1

Study Details

Study Description

Brief Summary

This study is investigating how N-Acetylcysteine (NAC), an over-the-counter medication, will reduce marijuana use when combined with Contingency Management, a behavioral treatment. It is hypothesized that marijuana dependent adolescents who are treated with NAC will use less marijuana during treatment when compared to adolescents who receive a placebo.

Condition or Disease	Intervention/Treatment	Phase
Cannabis Dependence	Drug: N-Acetylcysteine; Drug: placebo; Behavioral: Contingency Management	Phase 2

Detailed Description

This protocol involves investigation of N-Acetylcysteine (NAC) as a pharmacological treatment for cannabis dependence in adolescents. While recent advances have been made in psychosocial treatments for cannabis dependent adolescents, minimal work has been done to investigate the potential adjunctive role for pharmacotherapy in treatment. NAC is an inexpensive, over-the-counter agent with a favorable tolerability profile in adults and children, in common use since FDA approval in 1963. Preclinical and preliminary clinical research in adults suggests a role for NAC in addiction treatment via glutamate modulation.

Study Design

• Study Type: Interventional
• Actual Enrollment: 116 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Controlled Trial of N-Acetylcysteine (NAC) in Cannabis Dependent Adolescents
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: N-Acetylcysteine	Drug: N-Acetylcysteine; 1200 mg twice daily for 8 weeks; Other Names: NAC ; Behavioral: Contingency Management; rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule
Placebo Comparator: Placebo	Drug: placebo; 2 capsules twice daily for 8 weeks; Behavioral: Contingency Management; rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule

Outcome Measures

Primary Outcome Measures

1. Percentage of Negative Urine Cannabinoid Tests During Treatment [weekly during treatment, for 8 weeks]

   [Total number of negative urine tests per Group divided by the total number of urine tests per Group]*100

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 13-21 years

• Regular Marijuana smoker meeting DSM-IV criteria for cannabis dependence and seeking marijuana cessation treatment

Exclusion Criteria:

• Allergy or intolerance to NAC

• Pregnancy or lactation

• Use of carbamazepine or nitroglycerine (or any other drug deemed to be hazardous if taken with NAC) within 14 days of study participation

• Current enrollment in treatment for cannabis dependence

• Current substance dependence, other than cannabis or nicotine

• Significant medical or psychiatric illness that may place the participant at increased risk in the judgement of the study physician

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29403

Sponsors and Collaborators

• Medical University of South Carolina
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Kevin M Gray, MD, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kevin Gray, MD, Associate Professor, Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT01005810
• Other Study ID Numbers: 19152; R01DA026777
• First Posted: Nov 1, 2009
• Last Update Posted: Nov 21, 2018
• Last Verified: Nov 1, 2018

• Additional relevant MeSH terms: Marijuana Abuse; Acetylcysteine; N-monoacetylcystine

Study Results

Participant Flow

Arm/Group Title	N-Acetylcysteine	Placebo
Arm/Group Description	N-Acetylcysteine : 1200 mg twice daily for 8 weeks Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule	placebo : 2 capsules twice daily for 8 weeks Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule
Period Title: Overall Study
STARTED	58	58
COMPLETED	37	33
NOT COMPLETED	21	25

Baseline Characteristics

Arm/Group Title	N-Acetylcysteine	Placebo	Total
Arm/Group Description	N-Acetylcysteine : 1200 mg twice daily for 8 weeks Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule	placebo : 2 capsules twice daily for 8 weeks Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule	Total of all reporting groups
Overall Participants	58	58	116
Age (Count of Participants)
<=18 years	9 15.5%	9 15.5%	18 15.5%
Between 18 and 65 years	49 84.5%	49 84.5%	98 84.5%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	18.9 (1.5)	18.8 (1.5)	18.9 (1.5)
Sex: Female, Male (Count of Participants)
Female	19 32.8%	13 22.4%	32 27.6%
Male	39 67.2%	45 77.6%	84 72.4%
Region of Enrollment (Count of Participants)
United States	58 100%	58 100%	116 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Negative Urine Cannabinoid Tests During Treatment
Description	[Total number of negative urine tests per Group divided by the total number of urine tests per Group]*100
Time Frame	weekly during treatment, for 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	N-Acetylcysteine	Placebo
Arm/Group Description	N-Acetylcysteine : 1200 mg twice daily for 8 weeks Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule	placebo : 2 capsules twice daily for 8 weeks Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule
Measure Participants	58	58
Number [percentage of negative urine tests]	40.9	27.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	N-Acetylcysteine, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.029
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.35
	Confidence Interval	(2-Sided) 95%; 1.05 to 5.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	N-Acetylcysteine		Placebo
Arm/Group Description	N-Acetylcysteine: 1200 mg twice daily for 8 weeks Contingency Management: rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule		placebo: 2 capsules twice daily for 8 weeks Contingency Management: rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule
All Cause Mortality
	N-Acetylcysteine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/58 (0%)		0/58 (0%)
Serious Adverse Events
	N-Acetylcysteine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/58 (0%)		0/58 (0%)
Other (Not Including Serious) Adverse Events
	N-Acetylcysteine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	24/58 (41.4%)		27/58 (46.6%)
Gastrointestinal disorders
Abdominal pain	2/58 (3.4%)	2	1/58 (1.7%)	1
Decreased appetite	1/58 (1.7%)	1	3/58 (5.2%)	3
Heartburn	1/58 (1.7%)	1	0/58 (0%)	0
Nausea	0/58 (0%)	0	2/58 (3.4%)	2
Infections and infestations
Upper Respiratory Infection	11/58 (19%)	11	8/58 (13.8%)	8
Conjunctivitis	1/58 (1.7%)	1	0/58 (0%)	0
Nervous system disorders
Drowsiness	2/58 (3.4%)	2	2/58 (3.4%)	2
Headache	1/58 (1.7%)	1	3/58 (5.2%)	3
Psychiatric disorders
Insomnia	5/58 (8.6%)	5	8/58 (13.8%)	8
Irritability	1/58 (1.7%)	1	4/58 (6.9%)	4
Vivid dreams	6/58 (10.3%)	6	2/58 (3.4%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.